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ACU-HALT

FDA product code LDQ · 81 cleared devices

Unclassified

Clearance span: 1976-07-16 – 2000-01-20

LDQ 2000-01-20

EC-7701 FLUID WARMING CABINET

Applicant Enthermics Medical Systems, Inc.

K number K993797

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LDQ 2000-01-12

HOT SHOT FLUID WARMER IV FLUIDS

Applicant Infra-Med Technologies, Inc.

K number K992258

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LDQ 1998-09-02

PIV SYSTEM

Applicant Medical Solutions, Inc.

K number K981032

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LDQ 1998-05-07

CONTROLLED TEMPERATURE CABINET SYSTEM

Applicant Smith

K number K973747

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LDQ 1996-12-30

ACU-HALT

Applicant Glederer & Co., Inc.

K number K955661

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LDQ 1996-06-05

ACU-LAB

Applicant Glederer & Co., Inc.

K number K955776

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LDQ 1995-08-09

ACU-HALT

Applicant Eva-Health USA, Inc.

K number K945374

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LDQ 1995-08-07

PERSONAL ALARM SYSTEM (PAS)

Applicant Cytoprobe Corp.

K number K944961

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LDQ 1995-06-28

PALCO LABS COLD POUCH

Applicant Palco Laboratories, Inc.

K number K942810

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LDQ 1995-03-21

MEDICAL PROCEDURE TRAY, MODIFICATION

Applicant Enpak Medical Corp.

K number K930884

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LDQ 1994-01-26

MEDICOOL PROTECTALL

Applicant Avc Regulatory Compliance/Technical Services

K number K934703

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LDQ 1993-12-03

NORTEC STERILE WATER FOR DEVICE IRRIGATION

Applicant North American Sterilization & Packaging Co.

K number K925593

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LDQ 1993-12-03

NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI

Applicant North American Sterilization & Packaging Co.

K number K925588

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LDQ 1993-12-01

ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM)

Applicant Surface Mount Technology, Inc.

K number K932714

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LDQ 1993-11-18

ELPER(TM) BARRIER INTEGRITY MONITORING

Applicant Igea, S.R.L.

K number K931153

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LDQ 1993-10-12

DISP MONIT POUCH /GLOVE CK PAT EXAM GLOVE LEAK DET

Applicant Associated Ent., Inc.

K number K924837

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LDQ 1993-08-19

SURGIC-ALERT MONITOR

Applicant Novatec Medical Products, Inc.--Glove Monitor

K number K930514

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LDQ 1992-07-13

GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT.

Applicant Associated Ent., Inc.

K number K915636

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LDQ 1992-06-25

BARRIER INTEGRITY MONITOR

Applicant Incomed, Inc.

K number K915662

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LDQ 1992-02-18

GLOVE-CHEK PORTABLE FLUID LEAKAGE SENSING DEVICE

Applicant Vertex Technical Group, Inc.

K number K913696

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LDQ 1991-07-19

OLYMPIC WARMETTE

Applicant Olympic Medical Corp.

K number K911955

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LDQ 1990-11-20

MEDICAL PROCEDURE TRAY

Applicant Sorex Medical

K number K902410

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LDQ 1990-10-30

ACCU PATH STERILE LABEL

Applicant Accu-Path

K number K904598

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LDQ 1990-09-26

STICK-GARD STERILE CAP

Applicant Integrated Medical Systems, Inc.

K number K902682

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LDQ 1990-08-21

GLOVE LEAK DETECTOR

Applicant Utah Medical Products, Inc.

K number K901237

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LDQ 1990-05-11

SHARP-SAFE, BIODEGRADEABLE,DISP., NEEDLE DISP. BOX

Applicant Sharp Safe, Inc.

K number K901321

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LDQ 1990-05-02

WEINSTEIN STYLE INSTRUMENT HOLDER

Applicant David Ayres Medical Co.

K number K901486

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LDQ 1990-01-11

MEDICOOL, CONTAINER FOR STORING INSULIN

Applicant Medicool, Inc.

K number K895674

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LDQ 1989-10-13

UNIVERSAL LIGHT CABLE

Applicant Expanded Optics, Inc.

K number K894570

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LDQ 1989-07-25

SIEMENS CEILING STAND 800F, 800 AND 810

Applicant Siemens Medical Electronics

K number K891023

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LDQ 1989-06-15

SARNS MEDICAL CART

Applicant 3M Company

K number K892052

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LDQ 1989-04-26

INSU COOL

Applicant Dynex Trading Co.

K number K885055

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LDQ 1988-11-22

MULTI-PURPOSE HOLDER

Applicant Med-Dex Intl.

K number K884630

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LDQ 1988-07-13

MR. RAZOR II TWIN

Applicant Burney Products Corp.

K number K882388

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LDQ 1988-03-04

BLADE, SURGICAL PREP RAZOR STRAIGHT

Applicant Crescent Corp.

K number K880048

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LDQ 1987-12-29

BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE

Applicant Busse Hospital Disposables, Inc.

K number K874186

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LDQ 1986-12-12

STERILABELS

Applicant Diversatronics, Inc.

K number K864015

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LDQ 1986-10-16

SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES

Applicant Biological & Environmental Control Laboratories

K number K863633

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LDQ 1986-02-10

STUART GILMAN'S WEIGHT LOSS PLAN

Applicant Alpha Therapeutic Corp.

K number K854441

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LDQ 1985-08-20

CUDDLE CUSHION

Applicant The Cuddle Co.

K number K853185

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LDQ 1985-05-29

STERILE GENERAL HOSPITAL SUPPLIES

Applicant Biological & Environmental Control Laboratories

K number K851390

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LDQ 1985-05-15

ACTION PAC

Applicant South Mountain Medical

K number K851276

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LDQ 1984-07-03

DISPOS. POLY APRONS

Applicant Abco Dealers, Inc.

K number K842016

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LDQ 1984-02-04

STERILE LABELS

Applicant Devon Industries, Inc.

K number K834062

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LDQ 1983-12-22

STERILE RUBBER BANDS

Applicant Devon Industries, Inc.

K number K834063

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LDQ 1983-11-28

TOURNIQUET CUFF PRESSURE MONITOR #TCPM

Applicant Electromedics, Inc.

K number K832272

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LDQ 1983-07-18

PLASTIC DISPOSABLE RAZOR

Applicant I M, Inc.

K number K831799

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LDQ 1982-09-30

INFECTION CONTROL TOWEL

Applicant American Threshold Industries, Inc.

K number K822484

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LDQ 1982-06-09

OUT-RITE WASTE DISPOSABLE BAG

Applicant Kleen Test Products

K number K821396

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LDQ 1982-02-22

CARDIO-BAND

Applicant Cardio-Band, Inc.

K number K813566

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LDQ 1982-02-04

SAFETY PINS

Applicant Stan-Pak Ent.

K number K820052

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LDQ 1981-12-31

TRACHEOSTOMY CARE TRAY

Applicant E.M. Adams

K number K813260

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LDQ 1981-12-09

POSTURE MIRROR

Applicant Maddak, Inc.

K number K812479

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LDQ 1981-11-06

STERILE BASIN SETS

Applicant Medspec Corp.

K number K813012

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LDQ 1981-09-24

FOAM WEDGE

Applicant Maddak, Inc.

K number K812482

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LDQ 1981-08-20

CUDDLE CAP

Applicant Darcy, Inc.

K number K812216

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LDQ 1981-05-08

MINOR DRESSING TRAY

Applicant Cunningham Woodland, Inc.

K number K811091

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LDQ 1981-05-08

MAJOR DRESSING TRAY

Applicant Cunningham Woodland, Inc.

K number K811090

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LDQ 1981-05-08

ONE STEP PREP KIT

Applicant Cunningham Woodland, Inc.

K number K811089

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LDQ 1981-05-08

DRESSING TRAY MERCY HOSPITAL

Applicant Cunningham Woodland, Inc.

K number K811088

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LDQ 1981-03-30

DRESSING CHANGE TRAY-MEDIUM

Applicant Associated Medical Products Co.

K number K810570

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LDQ 1980-12-10

DR. MICHAEL'S FOOT HELPER

Applicant Dr. Michael'S Foot-Care Products

K number K802837

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LDQ 1980-10-23

AMPCO SHAVE PREP TRAYS, CAT.#SP4020

Applicant Associated Medical Products Co.

K number K802041

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LDQ 1980-10-10

NU-BORN BABY BATH KIT

Applicant American Hospital Supply Corp.

K number K802366

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LDQ 1980-09-16

AMPCO SKIN SCRUB TRAYS, CAT.#SS843

Applicant Associated Medical Products Co.

K number K802043

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LDQ 1980-09-16

AMPCO SKIN SCRUB TRAYS, CAT.#SS824

Applicant Associated Medical Products Co.

K number K802042

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LDQ 1980-09-09

AMPCO SKIN SCRUB TRAYS, CAT.#SS612

Applicant Associated Medical Products Co.

K number K802044

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LDQ 1980-09-09

PLASTIC DISPOSABLE RAZOR CAT.#1017,1018

Applicant Pollak (Intl.), Ltd.

K number K802003

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LDQ 1980-07-28

TUBE HOLDER

Applicant Devon Industries, Inc.

K number K801421

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LDQ 1980-02-01

CONPHAR SURGICAL RAZORR

Applicant Conphar, Inc.

K number K791798

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LDQ 1979-06-11

SANDEE SANDING BLOCK

Applicant Dr. Bertram L. Steel

K number K790504

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LDQ 1979-05-29

KAGER TRAPDUST

Applicant Kager Intl.

K number K790085

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LDQ 1978-12-05

SURGICAL PREP RAZOR

Applicant Warren J. Grosjean

K number K781437

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LDQ 1978-03-14

RAISED TOILET SEAT

Applicant Med Fusion Systems, Inc.

K number K772276

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LDQ 1978-03-14

TOILET SAFETY RAIL

Applicant Med Fusion Systems, Inc.

K number K772275

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LDQ 1978-02-21

CUT-DOWN BUILT-UP TOILET SEAT

Applicant Fred Sammons, Inc.

K number K772403

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LDQ 1977-04-05

ISOLATION KIT

Applicant American Hospital Supply Corp.

K number K770381

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LDQ 1976-08-11

RAZOR, SCHICK DISPOSABLE

Applicant Parke-Davis Co.

K number K760342

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LDQ 1976-08-11

RAZOR, DISPOSABLE

Applicant Devon Industries, Inc.

K number K760328

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LDQ 1976-07-20

BASIN, WASH, 6-QT RECTANGULAR

Applicant Bemis Health Care

K number K760073

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LDQ 1976-07-16

KIT, PREP SHAVE

Applicant M-C Ind., Inc.

K number K760052

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