Atlas FDA

1990

4,721 FDA 510(k) clearances · Clearance year

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RecordFirmDate
VACCON (K896733)Unoplast A/S1990-02-01
DEVILBISS MODEL PV02 SERIES (K896457)Devilbiss Health Care, Inc.1990-02-01
RECTILINEAR SCANNER MODEL #187-270 (K895799)Atomic Products Corp.1990-02-01
MODIFIED GLUMA BONDING SYSTEM (K896382)Heraeus Kulzer, Inc.1990-02-01
CARBON DIOXIDE REAGENT (K896590)Pointe Scientific, Inc.,1990-02-01
CYTOGUIDE FOR USE W/THE PHILMEDISYST MAMMODIAG UC (K896609)Philips Medical Systems North America, Inc.1990-01-31
PEDIATRIC DRAIN BAG (K896581)Laytech Medical Co.1990-01-31
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN (K896414)Baxter Healthcare Corp1990-01-31
DENTAL BRIDGE ANCHORING PINS (K896337)Gayso Bridge-Tech, Inc.1990-01-31
NKA MODELS AB-601G AND AB-621G (K900272)Nihon Kohden America, Inc.1990-01-31
AWC BUTTERFLY WOUND CLOSURES (K894802)American White Cross, Inc.1990-01-31
ANGIOSCOPY PUMP (K895074)Baxter Healthcare Corp1990-01-31
TRANSPARENT FILM I.V. SITE/WOUND DRESSING (K896421)Catalina Biomedical Corp.1990-01-31
ARTERIOVENOUS FISTULA SETS (K900125)Baxter Healthcare Corp1990-01-31
TITANIUM MODULAR COLLARED HIP PROSTHESIS (K895035)Depuy, Inc.1990-01-31
TITANIUM MODULAR MODULAR COLLARLESS HIP (K895036)Depuy, Inc.1990-01-31
SHAW KNEE MODULAR TIBIAL TRAY-POROUS (K894937)Johnson & Johnson Professionals, Inc.1990-01-31
SILICONE PLUG (K896678)Orthopedic Systems, Inc.1990-01-30
NOVELTY GRADUATION SUNGLASSES; NON-PRESCRIPTION (K900046)Gibson Greetings, Inc.1990-01-30
HSC UNIT ROD (K896603)Danek Medical, Inc.1990-01-30
PORGES ERCP CATHETERS (K896503)Porges Corp.1990-01-30
MODIFIED LH ENZYME IMMUNOASSAY TEST KIT (K896642)Medix Biotech, Inc.1990-01-30
VITRO T4-EIA-XT (K896865)In Vitro Diagnostics, Inc.1990-01-30
MODIFIED ASSESS(R) PEAK FLOW METER (K896953)Health Products, Inc.1990-01-30
KESTREL LENS CASE 731H-893S/P-1700-2611 (K900053)Kestrel1990-01-30
KESTREL LENS CASE 1543-893S/P-1700-2611 (K900054)Kestrel1990-01-30
PORGES UNIVERSAL HANDLES (K896505)Porges Corp.1990-01-30
PORGES CYTOLOGY BRUSHES (K896425)Porges Corp.1990-01-29
MODIFIED ELISA FOR CHLAMYDIA (K896032)Fairleigh Dickinson Laboratories, Inc.1990-01-29
EASI-LAV ADULT GASTRIC LAVAGE KIT (K896573)Clairson Industries, LLC1990-01-29
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (K896965)Alamar Biosciences Laboratory, Inc.1990-01-29
REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210) (K900017)Helena Laboratories1990-01-29
CONNECTION SHIELDS CODES 5C4213 AND 5C4215 (K895673)Baxter Healthcare Corp1990-01-29
DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 (K895631)Baxter Healthcare Corp1990-01-29
8400ST VOLUME VENTILATOR (K894322)Bird Products Corp.1990-01-29
MODIFIED QUINTON SINGLE LUMEN CATHETER (K896252)Quinton, Inc.1990-01-29
PASCO MIC/ID GRAM-POSITIVE PANEL (K895215)Difco Laboratories, Inc.1990-01-29
ACME COATED ORTHODONTIC ARCHWIRE (K895483)Acme-Monaco Corp.1990-01-29
MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-III (K896541)Valley Forge Scientific Corp.1990-01-29
QUANTUM HIP STEM (K896325)Depuy, Inc.1990-01-29
INPOUCH-TV POUCH (K896296)Biomed Diagnostics, Inc.1990-01-29
CLEARVIEW CHLAMYDIA (K895280)Unipath , Ltd.1990-01-29
PORGES DIATHERMY SNARE (K896507)Porges Corp.1990-01-29
GENESIS III, (MOD. 7003/7004) (K894370)Biosound, Inc.1990-01-29
LIFE DEFENSE PLUS(TM), DEFIBRILLATOR/MONITOR/PACER (K895533)Matrix Medica, Inc.1990-01-26
SYSTEMA ENT CABINET (K896273)Jedmed Instrument Co.1990-01-26
JEDMED S CHAIR (K896298)Jedmed Instrument Co.1990-01-26
PORGES 2-WAY BALLOON EXTRACTION CATHETER (K896504)Porges Corp.1990-01-26
ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) (K895906)Roche Diagnostic Systems, Inc.1990-01-26
MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR (K896809)Medtronic Vascular1990-01-26
JOBST ATHROMBIC PUMP(R) SYSTEM 2000 (K895732)Jobst Institute, Inc.1990-01-26
PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR (K896506)Porges Corp.1990-01-26
PATIENT EXAMINATION GLOVES (LATEX) (K891662)Darchet (Usa), Inc.1990-01-26
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (K896957)Honyee Enterprise Co.1990-01-26
SLEEPSCAN (K894155)Biologic Systems Corp.1990-01-26
POWDER-FREE LATEX EXAMINATION GLOVES (K895970)Usamal Latex Products Sdn Bhd1990-01-26
TYMPANOSCOPE (K896274)Jedmed Instrument Co.1990-01-26
HPD TUBING CONNECTORS (K895795)Hpd Medical, Inc.1990-01-26
DIRECTIGEN 1-2-3 INFECTIOUS MONONUCLEOSIS CONTROLS (K896926)Quidel Corp.1990-01-26
MATRX BATTERY CHARGER/DEFIBRILLATOR TESTER (K895525)Matrix Medica, Inc.1990-01-26
TYPE 9541 RECORDER, PAPER CHART (K895111)S & W Medico Teknik1990-01-26
EXPANSION OF THE CORDIS PTA DILATATION CATHETER (K894899)Cordis Corp.1990-01-26
VENTLAB ANESTHESIA CIRCUIT AC 6000 (K896897)Ventlab Corp.1990-01-26
SFA MODULE (K896528)Life Sciences Manufacturing, Inc.1990-01-26
MODIFIED HEARTSTART 2000 DEFIBRILLATION ELECTRODE (K900169)Laerdal Mfg. Corp.1990-01-26
WR3500 AND WR3600 SERIES RECORDERS (K894922)Western Graphtec1990-01-26
POWDER-FREE VINYL EXAMINATION GLOVES (K894686)Dynarex Corp.1990-01-26
SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 (K882955)Kontron Instruments, Inc.1990-01-26
OLYMPIA FACEPLATE MODULE (K896304)Olympia Instruments, Inc.1990-01-26
AMBULATORY CARDIAC MONITOR (K896064)Monitech, Inc.1990-01-26
BANDTITE GLASS IONOMER CEMENT (K896249)American Orthodontics1990-01-26
LATECHNICS LATEX EXAMINATION GLOVES (K892619)Ssangyong Corp. (M) Sdn. Bhd.1990-01-26
AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA. (K900164)Puritan Bennett Corp.1990-01-26
CLP ELEVATED LIPID CONTROL (K895858)Creative Laboratory Products, Inc.1990-01-26
AMBULATORY (HOLTER) RECORDING SYSTEM - MODIFIED (K895266)Biosensor Corp.1990-01-26
FLEXIBLE NASOPHARYNGOSCOPE (K896297)Jedmed Instrument Co.1990-01-26
PORGES SCLEROTHERAPY NEEDLES (K896424)Porges Corp.1990-01-26
LATEX NON-POWDERED EXAMINATION GLOVES (K896872)Thaisan Industries Co., Ltd.1990-01-25
HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE (K900150)Icor AB1990-01-25
ROCKET REFERENCE PLASMA, CAT NO. 5188 (K900019)Helena Laboratories1990-01-25
RAICHEM TM HEMOGLOBIN CALIBRATOR (K896921)Reagents Applications, Inc.1990-01-25
RAICHEM TM HEMOGLOBIN REAGENT (K896922)Reagents Applications, Inc.1990-01-25
APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT (K900049)Medical Diagnostic Technologies, Inc.1990-01-25
RESUBMITTED FECATWIN SENSITIVE - FECA-EIA (K896474)Labsystems, Inc.1990-01-25
CLEAN HAND-VCL GLOVE DISPENSER (K897048)Safety Today, Inc.1990-01-25
FACTOR II DEFICIENT PLASMA (K900133)Medical Diagnostic Technologies, Inc.1990-01-25
MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS (K896976)Asahi Medical Co., Ltd.1990-01-24
SPACELABS' MODEL 90514, MULTIGAS ANALYZER (K896427)Spacelabs, Inc.1990-01-24
PATIENT EXAMINATION GLOVES (LATEX) (K892300)Ryoden Intl., Ltd.1990-01-24
MODIFIED ANGIOGRAPHIC CATHETER (K896690)Novoste Corp.1990-01-24
SURGEON'S GLOVES (K895823)Guey Her Ent. Co. , Ltd.1990-01-24
ADAPTOR: KAPS CINE TO MOELLER BEAMSPLITTER (K900160)Jedmed Instrument Co.1990-01-24
IMMUNODOT AUTOIMMUNITY SCREENING PANEL 2 (K900072)General Biometrics, Inc.1990-01-24
MILLAR MIKRO-TIP DOPPLER CATHETER (K896264)Millar Instruments, Inc.1990-01-24
MODEL EC4542G MINIATURE (K896352)Pace Medical1990-01-24
MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT (K896664)Asahi Medical Co., Ltd.1990-01-24
LATEXINDO LATEX EXAMINATION GLOVES (K896906)P.T. Latexindo Sejahtera1990-01-24
THORA-KLEX CHEST DRAINAGE UNIT (K896127)Davol, Inc.1990-01-24
PROGUARD II(TM) (K896086)Safety-Ject, Inc.1990-01-24
4/1 ARMBOARD (K900175)Infection Control Products, Inc.1990-01-24
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Every clearance here is in the API, with alerts when new ones post.