Atlas FDA

1988

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

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RecordFirmDate
TURBOX ANTITHROMBIN III (K884144)Unipath , Ltd.1988-12-20
DC-1 I.V. DOSAGE COMPUTER (K884016)Phase Medical, Inc.1988-12-20
AUTOEXPANDABLE SPECULUM MODEL LEIBOVICH SMALL #2 (K880586)C.I.S.A. Import Export C/O Larson and Taylor1988-12-20
TURBOX FIBRINOGEN (K884179)Unipath , Ltd.1988-12-20
ERYTHROPOIETIN ENZYME IMMUNOASSAY (K882686)Amgen, Inc.1988-12-20
VOXELSCOPE(TM) (K884268)Dynamic Digital Displays, Inc.1988-12-20
MODIFICATION OF MONO-PLUS(TM) (K883709)Armkel, LLC1988-12-20
ROCKET INTRAUTERINE DEPTH SOUND (K884684)A & A Medical, Inc.1988-12-20
MODIFIED 10CC SYRINGE CONTROL RING SET (K884985)Procedure Products, Inc.1988-12-20
UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA. (K884359)Automatic Liquid Packaging, Inc.1988-12-20
AUTOEXPANDABLE SPECULUM MODEL LEIBOVIC LARGE #4 (K880588)C.I.S.A. Import Export C/O Larson and Taylor1988-12-20
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM (K884317)Medrad, Inc.1988-12-20
LUXAR ENDOGUIDE CO2 LASER WAVEGUIDE (K884459)Luxar Corp.1988-12-19
CREATININE TEST (CREA) ITEM #65663 (K884734)Em Diagnostic Systems, Inc.1988-12-19
HEARING AID WIDEX BTE (K884113)Widex Hearing Aid Co., Inc.1988-12-19
DOUBLE CLOSED URINARY DRAINAGE SYSTEM (K883886)Knight Medical, Inc.1988-12-19
MODIFIED IMED GEMINI PC-1 INFUSION PUMP (K883993)Imed Corp.1988-12-19
FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST (K883530)Tambrands, Inc.1988-12-19
GONIOMETER AND BIOMEDICAL RECORDER SYSTEM (K884003)Penny & Giles Blackwood , Ltd.1988-12-19
INTRAVASCULAR ADMINISTRATION SET (K883764)Device Labs, Inc.1988-12-19
CO2 LASER SYSTEM & ARTHOGUIDE CO2 LASER FIBER DEL. (K883488)Heraeus Lasersonics, Inc.1988-12-19
THAIRAPY(TM) BRONCHIAL DRAINAGE SYSTEM, MODEL 101 (K884098)American Biosystems, Inc.1988-12-16
CHLAMYDIAZYME/COMMANDER INSTRUMENTATION (K885006)Abbott Laboratories1988-12-16
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE) (K884355)Eastman Kodak Company1988-12-16
LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73 (K883615)Supelco, Inc.1988-12-16
MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS (K883606)Hewlett-Packard Co.1988-12-16
PHOSPHORUS TEST (PHOS) ITEM #65666 (K884735)Em Diagnostic Systems, Inc.1988-12-16
OXINET N-7500 PULSE OXIMETRY NETWORK (K884142)Nellcor, Inc.1988-12-16
NEUROWAVE SYSTEM 2 (K883557)Durden Enterprises, Inc.1988-12-16
PEDIATRIC HUMIDIFIER TUBE W/ TEMPERATURE PORT (K884525)Intertech/Ohio1988-12-16
TDX METHADONE ASSAY (K884968)Abbott Laboratories1988-12-16
DSM-1 DOSIMETER (K884051)S & M Instrument Co.1988-12-16
AIRWAY-CIRCULATION EVALUATOR (K881483)Resuscitation Ace, Inc.1988-12-16
T.E.N.S. UNIT SIGMA & TX-3 (K883188)Diamond Medical Equipment, Inc.1988-12-16
HDL-CHOLESTEROL PRECIPITATING REAGENT (K883543)Medical Analysis Systems, Inc.1988-12-16
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER (K884329)Baxter Healthcare Corp1988-12-16
MRL PACETTE, 450SLL (K880932)Medical Research Laboratories, Inc.1988-12-16
NAPARIMA BIORESISTANCE METER & BODY COMP. ANALYZER (K883919)Naparima, Inc.1988-12-16
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM (K884063)C.R. Bard, Inc.1988-12-16
EZ-SCREEN CANNABINOID/COCAINE (K883105)Environmental Diagnostics, Inc.1988-12-16
TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS (K884224)A-Kem, Inc.1988-12-15
UROIMAGER (K883925)Ausonics Pty , Ltd.1988-12-15
ABC FP ANALYZER (K883533)Intl. Bioclinical, Inc.1988-12-15
ALLEN PRONE ARMBOARD (K884838)Edgewater Medical Systems, Inc.1988-12-15
BIODOP(TM) (K883334)Diagnosis Related Systems, Inc.1988-12-15
LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) (K884424)Bio-Rad1988-12-15
IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 (K884278)Telectronics, Inc.1988-12-15
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST (K882440)Zeus Scientific, Inc.1988-12-15
S 4 INSTRUMENT STAND (K884876)Carl Zeiss, Inc.1988-12-15
SHARPLAN-MEDILAS 4060N YAG LASER & SERIES 2900 TIP (K884994)Sharplan Lasers, Inc.1988-12-15
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES (K882447)Zeus Scientific, Inc.1988-12-15
JOHNSON & JOHNSON STERILE SPRAY TIP SYRINGE (K884749)Johnson & Johnson Patient Care, Inc.1988-12-15
UNIVERSAL(TM) ION SELECT ELECTRODE STANDARDS (K884693)Biomedical Research & Development Laboratories, Inc.1988-12-15
FREE ARM(TM) (K884928)Faro Medical Technologies, Inc.1988-12-15
MODIFIED JELTRODE(TM) ELECTRODES DEEMED (K884348)Henley Intl.1988-12-15
OCCUSHIELDS (K884929)Dioptics1988-12-15
CENTURY COLOR TRACE (K884152)Biomedical Systems, Inc.1988-12-15
THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL (K883726)Immuchem Corp.1988-12-15
TAB PAK (K882731)Dynex Trading Co.1988-12-14
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 (K884377)Em Diagnostic Systems, Inc.1988-12-14
TOTAL IRON BINDING CAPACITY TEST (K884649)Sclavo, Inc.1988-12-14
PUMPETTE(TM) (K884111)Helena Laboratories1988-12-14
DELFIA THYROXINE (T4) KIT (K883559)Pharmacia, Inc.1988-12-14
RAICHEM(TM) BILIRUBIN CONJUGATE STANDARD (K883389)Reagents Applications, Inc.1988-12-14
VERSABLOT (K884258)American Bionetics, Inc.1988-12-14
DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET (K884197)Casco Standards1988-12-14
WWDS-005 HUMAN RECTAL PROBE (K883079)Ausonics Pty , Ltd.1988-12-14
SLT CONTACT LASER SYSTEM CYCLOPHOTOCOAGULATION (K882679)Surgical Laser Technologies, Inc.1988-12-14
FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (K884201)Cyberfluor, Inc.1988-12-14
WASHER 500 MICROELISA SYSTEM (K884695)Organon Teknika Corp.1988-12-13
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM (K884318)Abbott Laboratories1988-12-13
TARGET THERAPEUTICS SEEKER-16 STEERABLE GUIDEWIRE (K884198)Target Therapeutics1988-12-13
COATEST PROTEIN C (K884058)Kabivitrum, Inc.1988-12-13
SANIFIX (K883983)Iberhospitex, S.A.1988-12-13
MANUAL PERCUSSOR CUPS (K883899)Medical Components, Inc.1988-12-13
IRRIGATION KIT (K883506)L H M Ent., Inc.1988-12-13
LYME DISEASE IFA (IGG) (K883487)Hillcrest Biologicals1988-12-13
CFX 625 (K883976)Fischer Imaging Corp.1988-12-13
HARBOR S.E.A.-PORT SURGICAL ACCESSORY KIT (K882657)Harbor Medical Devices, Inc.1988-12-13
DANNINGER TRIMCHECK(TM) PORTABLE & DESK TOP MODELS (K881841)Buckman Co., Inc.1988-12-13
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK (K884543)Sechrist Industries, Inc.1988-12-13
CATHETER, INTRAUTERINE AND INTRODUCER (K883832)Telos Medical Corp.1988-12-13
WOODEN SPECTACLE FRAMES (K884272)Woodwave1988-12-12
FLO-GARD VP (K884014)Baxter Healthcare Corp1988-12-12
INVACARE YOUTHMOBILE 5000 SERIES WHEELCHAIR (K884932)Invacare Corp.1988-12-12
MIKADO AC 405 (K883837)Ivex Medical, Inc.1988-12-12
SDU-500 DIAGNOSTIC ULTRASOUND INSTRUMENT (K875187)Shimadzu Corp.1988-12-12
CONTROL SYRINGE (K884497)Professional Medical Services1988-12-12
ROLLS 3000 SERIES WHEELCHAIR (YOUTHMOBILE) (K884931)Invacare Corp.1988-12-12
UV AIR STERILIGHT (K884579)Allseasons Environmental Control, Inc.1988-12-12
CATHSCANNER INTRAVASCULAR ULTRASONIC IMAGING SYST. (K883888)Advanced Biosearch Assn.1988-12-12
ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. (K882289)Aries Medical, Inc.1988-12-12
TX-7 (TENS) (IC-1107) (K884210)Oms Medical Supplies, Inc.1988-12-12
SERUM HCG MICROASSAY (K884430)Diamedix Corp.1988-12-09
ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 (K883839)Marlo Surgical Technology1988-12-09
ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM (K883817)Boehringer Mannheim Corp.1988-12-09
AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (K884226)A-Kem, Inc.1988-12-09
RUBIN BONE PLANER W/REPLACEABLE BLADE (K884473)Neo Contemporary Co.1988-12-09
TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS (K884225)A-Kem, Inc.1988-12-09
MODIFIED CEDIA TOTAL T4 ASSAY (K884634)Microgenics Corp.1988-12-09
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Every clearance here is in the API, with alerts when new ones post.