Atlas FDA

1988

4,299 FDA 510(k) clearances · Clearance year

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RecordFirmDate
DANNINGER ORTHOPAEDIC AWL (K875223)Danninger Medical Technology, Inc.1988-02-17
VOLZ TOTAL WRIST PROSTHESIS (K880156)Biomet, Inc.1988-02-17
MULTI-ALLERGEN IGE FAST SCREEN (MOLDS) (K880002)3M Company1988-02-17
SPECTRON EF ACETABULAR COMPONENT (K874619)Richards Medical Co., Inc.1988-02-17
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R)) (K875274)Incstar Corp.1988-02-17
FIAGEN(TM) THYROXINE (T4), CATALOGUE #101-101 (K874623)Cyberfluor, Inc.1988-02-16
IV EXTENSION SET (K875186)Marquette Medical, Inc.1988-02-16
MODEL 938 BATHING SYSTEM (K880355)Ferno Ille-Forge1988-02-16
MOBILIMB HAND C.P.M. UNIT (K880336)Toronto Medical Corp.1988-02-16
STRATUM ESU (K874719)Alternative Design Systems, Inc.1988-02-16
60 ML RESERVOIR BAG, ITEM #200 (K875155)Prn Services, Inc.1988-02-16
L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA (K874328)E.I. Dupont DE Nemours & Co., Inc.1988-02-16
DISPOSABLE SYRINGE (K875097)California Ent.1988-02-16
TATUNG'S DENTURE CLEANING SOLUTION (K874805)Tatung Company of America, Inc.1988-02-16
STERLING (MOTORIZED VEHICLE) (K880425)A-Bec Mobility, Inc.1988-02-16
HASTING FINGER FIXATOR INSTRUMENTS (K880046)Buckman Co., Inc.1988-02-16
YUE/FA DISPOSABLE SYRINGE (K880350)Honway International Co.1988-02-16
RAMP HERPES SIMPLEX VIRUS (HSV) (CCT) (K874863)Monoclonal Antibodies, Inc.1988-02-16
TECHNICON SMAC 3 SYSTEM (K875105)Technicon Instruments Corp.1988-02-16
TARGA (WHEELCHAIR) (K880423)A-Bec Mobility, Inc.1988-02-16
STERILE SURGICAL NATURAL LATEX GLOVES (K875349)Marand Products, Inc.1988-02-16
NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (K880376)Genesis Industries, Inc.1988-02-16
MODIFIED AIR FLUIDIZED BED, KINAIR (K880340)Kinetic Concepts, Inc.1988-02-16
ADCOMP 4000 HP SYSTEM (K874495)Healthtek, Inc.1988-02-16
ABUSCREEN(R) EIA AMPHETAMINE (K874836)Roche Diagnostic Systems, Inc.1988-02-16
SCOOTA BUG (MOTORIZED VEHICLE) (K880424)A-Bec Mobility, Inc.1988-02-16
JMS TRANSFUSION SET (K880174)Jms Co., Ltd.1988-02-16
OXYGEN/PULSE MONITOR (K875031)Healthdyne, Inc.1988-02-12
SHIMADZU CATHETERIZATION C-ARM STAND ER-200 (K875372)Shimadzu Precision Instruments, Inc.1988-02-12
C900 X-RAY FILM PROCESSOR (K874908)Summit Industries, Inc.1988-02-12
AMICI KRYPTON ADMINISTRATION SYSTEM* (K872920)Amici, Inc.1988-02-12
PERMANENT MYOCARDIAL LEADS MP SERIES (K872971)Oscor Medical Corp.1988-02-12
SHIMADZU CATHETERIZATION C-ARM STAND MH-50B (K875376)Shimadzu Precision Instruments, Inc.1988-02-12
SHIMADZU MAMMOGRAPHIC STAND MR-30 (K875377)Shimadzu Precision Instruments, Inc.1988-02-12
MOBILE PAK, MODEL AC (K880261)Intl. Biomedical Concepts, Inc.1988-02-12
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES (K880247)Shiley, Inc.1988-02-12
BEAR NVM-1 (K872660)Bear Medical Systems, Inc.1988-02-12
SHIMADZU LATERAL C-ARM MH-30 (K875375)Shimadzu Precision Instruments, Inc.1988-02-12
SHIMADZU CATHETERIZATION C-ARM STAND MH-10 (K875380)Shimadzu Precision Instruments, Inc.1988-02-12
MODEL 8800 CARDIORESPIRATORY OXIMETER (K874947)Nonin Medical, Inc.1988-02-12
C-ARM STAND FOR BIPLANCE CINE FLUOROGRAPHY MH-20 (K875373)Shimadzu Precision Instruments, Inc.1988-02-12
THE PROTECTOR (K874412)Tri Jon, Inc.1988-02-12
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100 (K872896)American Bentley1988-02-12
SHIMADZU CEILING-SUSPENDED C-ARM CH-50 (K875374)Shimadzu Precision Instruments, Inc.1988-02-12
STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407 (K875058)Busse Hospital Disposables, Inc.1988-02-12
LUNG DIFFUSION GAS (K873586)National Welders1988-02-12
SHIMADZU CEREBRAL ANGIOGRAPHIC UNIT ER-100A (K875379)Shimadzu Precision Instruments, Inc.1988-02-12
TARGET PROGRAM & EPSON HX-20 COMPUTER (K872877)Walter Lorenz Surgical, Inc.1988-02-12
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE (K875059)Daig Corp.1988-02-12
ACS SOFT-TIP CORONARY INFUSION CATHETER W/SIDEHOLE (K875269)Advanced Cardiovascular Systems, Inc.1988-02-12
BIOSURGE MODEL OASYS-II (K875023)Biosurge, Inc.1988-02-12
MOBILE PAK, MODEL DC (K880262)Intl. Biomedical Concepts, Inc.1988-02-12
TRACKER-25 INFUSION CATHETER (K874751)Target Therapeutics1988-02-12
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT (K874782)Diagnostic Products Corp.1988-02-11
IRON PROCEDURE (K874918)Data Medical Associates, Inc.1988-02-11
OMNIPLANE 200 FILM CHANGER SYSTEM (K874451)Medrad, Inc.1988-02-11
REVISED LABELING FOR ADX OPIATES (K880010)Abbott Laboratories1988-02-11
T4 SEROZYME ENZYMEIMMUNOASSAY KIT/MAG. SOLID PHASE (K874866)Serono Diagnostics, Inc.1988-02-11
REVISIED LABELING FOR ADX BENZODIAZEPINES (K880014)Abbott Laboratories1988-02-11
MENTOR BLACK LIGHT URETERAL STENT SET (K873557)Mentor Corp.1988-02-11
MEDEX MACHINE (K880032)Medex, Inc.1988-02-11
UREA NITROGEN (BUN) (K880078)Tech-Neal Scientific, Inc.1988-02-11
VAN-TEC DOUBLE OCCLUSION BALLOON CATHETER (K874112)Van-Tec, Inc.1988-02-11
P-S MEDICAL VENTRICULAR ACCESS PORT (K874468)Pudenz-Schulte Medical Research Corp.1988-02-11
STRYKER 1990 LIBERTY ELECTRIC CRITICAL CARE BED (K875037)Stryker Corp.1988-02-11
MINIMED III INFUSION PUMP & UNI-SET ADMIN SET (K874564)Medtronic Minimed1988-02-11
WAKO(TM) PRETEST 6A (K873409)Wako Chemicals USA, Inc.1988-02-11
MASK, OXYGEN (K874092)Life Support Products, Inc.1988-02-11
MODEL 820 TOP=TRAK (K873039)Sierra Laboratories, Inc.1988-02-11
HEALTHDYNE RATE METER (K874814)Healthdyne, Inc.1988-02-11
EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 (K875062)Em Diagnostic Systems, Inc.1988-02-11
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL (K874832)Nova Biomedical Corp.1988-02-11
FINNIGAN MAT TSQ-70 (K880089)Finnigan Corp.1988-02-11
MEDICRAT, HYPODERMIC SYRINGES & NEEDLES (K875148)Knowltech Ind., Inc.1988-02-11
DISPOSABLE CORONARY CONTROL SYRINGE 12CC (K875196)Merit Medical Systems, Inc.1988-02-11
DUAL-CURE RADIOPAQUE (K874189)Pentron Corp.1988-02-11
MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT) (K874903)Simmler, Inc.1988-02-11
OXYGEN SUPPLY CONTROL REGULATOR (OSCR) (K874804)Transamerica Products, Inc.1988-02-11
IMMPULSE T4 ASSAY REAGENTS (K875081)Sclavo, Inc.1988-02-11
REVISED LABELING FOR ADX PHENCYCLIDINE (K880011)Abbott Laboratories1988-02-11
REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY (K880181)Reganes, Inc.1988-02-11
MALLEABLE PTFE COATED BRAIN SPATULAE (K880278)Downs Surgical , Ltd.1988-02-11
CALCIUM ASSAY KIT, NUMBER 120-19 (K874496)Diagnostic Chemicals, Ltd. (Usa)1988-02-11
PULSOR, THERAPEUTIC VIBRATOR (K874716)Gmg Enterprises, Inc.1988-02-11
LEECO PREGNASTICK (EIA) CATALOG #003 (K880069)Leeco Diagnostics, Inc.1988-02-11
CSF-VENTRICULOSTOMY RESERVOIR (K874498)Pudenz-Schulte Medical Research Corp.1988-02-11
QM2/QM300 CONTROL B PACK (K875283)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-10
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK (K875281)Kallestad Diag, A Div. of Erbamont, Inc.1988-02-10
SURGICAL BLADES (K880244)Ailee C/O Havel'S, Inc.1988-02-10
INFECTIOUS MONONUCLEOSIS (IM) CARD & LIQUID TEST (K880148)Ampcor, Inc.1988-02-10
LIPOGEN ANA TEST KIT (K875246)Lipogen, Inc.1988-02-10
RF CARD TEST & RF LIQUID TEST (K880164)Ampcor, Inc.1988-02-10
IMMUNOGLOBULIN G & G SUBCLASSES (K875356)Birmingham1988-02-10
GEMINI SURGICAL LIGHT (K880198)American Sterilizer Co.1988-02-10
THERMAL-PAK MODEL SW 1000 (K880252)Micro Tek Engineering1988-02-10
COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 (K874873)Diagnostic Products Corp.1988-02-10
FIBRINOSTICON (K880077)Organon Teknika Corp.1988-02-09
CALIBRATION REFERENCE PLASMA (K874940)Baxter Healthcare Corp1988-02-09
OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE (K875197)Pro-Optics, Inc.1988-02-09
RETICULOCYTE STAIN (K875310)Sigma Diagnostics, Inc.1988-02-09
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