Atlas FDA

1988

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

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RecordFirmDate
MODIFIED TORAY FILTRYZER DIALYZERS (K882158)Toray Industries (America), Inc.1988-08-12
DENTAL FLOSS PICK (K882828)Bik Pik1988-08-12
MINIMON 7131B PATIENT MONITOR (K882197)Kontron Instruments, Inc.1988-08-12
KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH (K881667)The Kendal Co.1988-08-12
BINAX EQUATE GLYCOHEMOGLOBIN (K874749)Binax, Inc.1988-08-12
GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER (K881723)Biosound, Inc.1988-08-12
TRIAD ORTHODONTIC GEL (K882482)Dentsply Intl.1988-08-12
FORTIFY (K882915)Bisco, Inc.1988-08-12
REBUILDING STERILIZERS (K882713)Mdt Corp., Inc.1988-08-12
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP (K881678)Hollister, Inc.1988-08-11
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA. (K880581)Synectics-Dantec1988-08-11
OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR (K881665)Omnitron Intl., Inc.1988-08-11
PERFUSOR M SYRINGE PUMP (K882106)Burron Medical, Inc.1988-08-11
VTR-12 (K882176)Eigen1988-08-11
SURGITEK CO2 DELIVERY SYSTEM (K881736)Medical Engineering Corp.1988-08-11
MODEL 90DX MULTITEST METER (K882032)Mesa Medical, Inc.1988-08-11
PERFUSOR SECURA SYRINGE PUMP (K882107)Burron Medical, Inc.1988-08-11
DPS-33,000 WITH CENTOR OPTION (K881017)Adac Laboratories1988-08-11
INTERSEPT* OXYGEN GAS LINE FILTER (K882136)Medtronic Blood Systems, Inc.1988-08-11
CENTRIX TRI-LAMINATE POST SYSTEM (K882125)Centrix, Inc.1988-08-11
VIEWPOINT (K882205)Adac Laboratories1988-08-11
MIC NEEDLE JEJUNOSTOMY TUBE KIT (K880767)Medical Innovations Corp.1988-08-11
FIRST AMERICAN, RADIONIC, JKR, MODEL AC (K881480)Jkr Laboratories, Inc.1988-08-11
IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL (K882690)3M Company1988-08-11
ENTRUST(TM) MODEL 800 (K882047)Avi, Inc.1988-08-11
PLEURAL BIOPSY PUNCH NEEDLE (K881624)E.G. Dick & Assoc.1988-08-11
INDICATENS 4X4 (K881708)Acudata Software1988-08-11
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS. (K881899)Diagnostic Products Corp.1988-08-10
CASF STERILIZATION TRAY (K883193)Terray Manufacturing, Inc.1988-08-10
CENTRIX NEEDLETUBE (K882651)Centrix, Inc.1988-08-10
EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM (K882744)Effner, Inc.1988-08-10
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5 (K882644)Huntleigh Technology, Inc.1988-08-10
CASF STERILIZATION TRAY (K883125)Terray Manufacturing, Inc.1988-08-10
C-MASK (K882882)Promedica Products, Inc.1988-08-10
C-MASK(FLAT) (K882883)Promedica Products, Inc.1988-08-10
LASERMATIC SURGILASER MODEL 5050 (K870587)Lasermatic OY1988-08-10
LAMINARIA CUREX (K881295)Harold W. Berger Co.1988-08-10
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP (K881471)Kimberly-Clark Corp.1988-08-10
MX350 (SERIES) CONTROL SYRINGE (K883094)Medex, Inc.1988-08-10
ELGILOY (K883074)Dale T. Dupuis1988-08-09
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT (K882334)Abbott Laboratories1988-08-09
MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE (K882448)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-08-09
FOLEY-TEMP(TM) (K882130)Mallinckroot, Inc.1988-08-09
INTERTECH LARGE VOLUME WATER TRAP (LVW) (K882739)Intertech Resources, Inc.1988-08-09
MONOJECT(R) SNAP-OVER SAFETY CAP (K882614)Sherwood Medical Co.1988-08-09
LAITINEN'S TRIGEMINUS STEREOGUIDE (K881132)Sandstrom Trade & Technology, Inc.1988-08-09
HEARING AID, UNITRON MODEL UI5 (K882375)Unitron Industries, Inc.1988-08-09
DERMAPIK (K882360)Creative Scientific Equipment Corp.1988-08-09
SCOPIX VIDEO IMAGER (K882096)Agfa-Gevaert, Inc.1988-08-09
IMPLANTOFIX II IMPLANTABLE DRUG DELIVERY SYSTEM (K881342)Burron Medical, Inc.1988-08-09
FIBRINOGENTEST-O (K881685)Diatech, Inc.1988-08-09
X-RAY MARKER (K882519)Karlin Technology, Inc.1988-08-09
BATTLE CREEK PILLOW (K882264)Battle Creek Equipment Co.1988-08-09
NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS (K875127)Novoste Corp.1988-08-09
SAFETY, BLOOD COLLECTION TUBE HOLDER (K882880)Ryan Medical, Inc.1988-08-09
PROFILE ONE OMNI (K882559)Modular Diagnostic Systems, Inc.1988-08-08
PHARMACIA IGE RIA ULTRA (K882625)Pharmacia, Inc.1988-08-08
SERIES 40 & SERIES 42 CRYOPROBES (R SERIES) (K882962)Spembly Medical , Ltd.1988-08-08
CLEAR EYE GARTER SHIELD (K880489)Eye Garter Company, Inc.1988-08-08
A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM (K882586)A-Kem, Inc.1988-08-08
A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM (K882587)A-Kem, Inc.1988-08-08
CLEANTECH SYSTEM (K882539)Schiff & Co.1988-08-08
SPEMBLY MEDICAL 142 CRYO UNIT (K882963)Spembly Medical , Ltd.1988-08-08
WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM (K882890)Thackray USA1988-08-08
COTUBE HCG IRMA TEST (K882155)Bio-Rad1988-08-08
SOLID PHASE EXTRACTION TUBES (K881361)Supelco, Inc.1988-08-08
VERIMED MYO/PREMS (K874212)Verimed Holdings, Inc.1988-08-08
EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 (K882719)Em Diagnostic Systems, Inc.1988-08-08
TELSTETH TELEMETRIC STETHOSCOPE(TM) (K882119)Quantsonics, Inc.1988-08-08
AMERLITE TOTAL THYROID CONTROL SERA LAN.4001 (K882727)Amersham Corp.1988-08-08
LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA (K882340)Serono Diagnostics, Inc.1988-08-08
REVISED DOUBLE ANTIBODY AMPHETAMINE (K882228)Diagnostic Products Corp.1988-08-08
EMIT HVA CANNABINOID 100 NG ASSAY (K882819)Syva Co.1988-08-08
MAGNESIUM REAGENT SET (K882256)Tech-Neal Scientific, Inc.1988-08-08
IMX CKMB (K883013)Abbott Laboratories1988-08-08
EMIT HVA BARBITURATE ASSAY (K882611)Syva Co.1988-08-08
REP HDL ELECTROPHORESIS METHOD (K882368)Helena Laboratories1988-08-08
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM (K882812)Osteonics Corp.1988-08-08
SURGEONS GLOVES (K881374)Interpro Intl., Inc.1988-08-05
ITE HEARING AID, EAR-TRONICS MODELS: M1-M23 (K881299)Ear-Tronics, Inc.1988-08-05
SCHIFF REAGENT (K883217)Surgipath Medical Industries, Inc.1988-08-05
8800 SERIES MICRO-PROCESSOR-BASED APNEA MONITORS (K862747)Atlas Researches , Ltd.1988-08-05
GL-35 COLPOSCOPIC LASER SYSTEM (K875314)Laser Engineering, Inc.1988-08-05
MEDITRON MG-1000 MONOPOLAR GENERATOR (K882049)Xylog Corp.1988-08-05
LAURIER SANITARY NAPKIN (K882768)Kao Corp.1988-08-05
NUTRIENT MIXTURE F-12 (HAM) NO. 200-2071 (K882993)J R Scientific1988-08-04
MCCOY'S 5A MEDIUM NO. 210-3530 (K882986)J R Scientific1988-08-04
CIRCULATING IMMUNE COMPLEXES CONTROLS (K882829)Cytotech, Inc.1988-08-04
RPMI-1640 BAKER'S MODIFICATION NO. 200-2078 (K882990)J R Scientific1988-08-04
(DME/F-12 1:1), CATALOG NO. 200-2100 (K882997)J R Scientific1988-08-04
EXL-14 MEDICAL LINEAR ACCELERATOR (K880200)Mitsubishi Intl. Corp.1988-08-04
BEAR 3 VENTILATOR (K881335)Bear Medical Systems, Inc.1988-08-04
FIAGEN FERRITIN (K882822)Cyberfluor, Inc.1988-08-04
BALL TIP FULGURATING ELECTRODE, 3 FRENCH (K880748)Cook Urological, Inc.1988-08-04
OCU-FILM TIP COVER (K882750)Oculab, Inc.1988-08-04
NUTRIENT MIXTURE F-12 (HAT VARIATION) NO. 200-2070 (K882991)J R Scientific1988-08-04
MINIMUM ESSENTIAL MEDIUM, ALPHA MODI. NO.200-2091 (K882992)J R Scientific1988-08-04
FISCHER'S MEDIUM NO. 200-2188 (K882995)J R Scientific1988-08-04
QRK 100, QUALITATIVE RING KERATOSCOPE (K882902)Technitex, Inc.1988-08-04
MERIFLUOR(TM) PNEUMOCYSTIS (K881608)Meridian Diagnostics, Inc.1988-08-04
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Every clearance here is in the API, with alerts when new ones post.