Atlas FDA

1987

4,160 FDA 510(k) clearances · Clearance year

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RecordFirmDate
SABOURAUD DEXTROSE (SD) AGAR, PRODUCT #P3330 (K873327)Lakewood Biochemical Co., Inc.1987-10-02
CIPRO SENSITIVITY DISKS (K873829)Difco Laboratories, Inc.1987-10-02
CREATININE REAGENT (K873365)Sigma Diagnostics, Inc.1987-10-02
SABOURAUD DEXTROSE SD EMMONS MOD. AGAR SLT TUBE (K873325)Lakewood Biochemical Co., Inc.1987-10-02
MULTICHEM CALCIUM S0910 (K873697)Simmler, Inc.1987-10-02
HEKTOEN ENTERIC (HE) AGAR PRODUCT #P3330 (K873329)Lakewood Biochemical Co., Inc.1987-10-02
SABOURAUD DEXTROSE - EMMONS AGAR PLATE #P3252 (K873328)Lakewood Biochemical Co., Inc.1987-10-02
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 (K873551)Em Diagnostic Systems, Inc.1987-10-02
CUSHION TREAD WALKING HEEL PRODUCT NO. 4183-135 (K873717)Martin Medical1987-10-02
SABOURAUD DEXTROSE SD AGAR SLT TUBE W/C&C #T4412 (K873323)Lakewood Biochemical Co., Inc.1987-10-02
CIPROFLOXACIN 5 MCG SUSCEPTIBILITY DISK (K873707)Organon Teknika Corp.1987-10-02
SAMUELSON ACETABULAR CUP (K872985)Protek, Inc.1987-10-01
MCCUTCHEN ACETABULAR CUP PROSTHESIS (K872732)Dow Corning Wright1987-10-01
HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES (K873742)Hood Laboratories1987-10-01
MYOSTIM(TM), MODEL 6600 (K872753)Medical Devices, Inc.1987-10-01
MDS-90 ARGON DYE LASER FOR DERMATOLOGY (K872578)Meditec of America1987-10-01
TL 400 TOTALAB VASCULAR DIAGNOSTIC SYSTEM (K872517)D. E. Hokanson, Inc.1987-10-01
SIEGEN NEUROSCOPE SEEG FOR EVOKED RESPONSE STIMU. (K871964)Siegen Corp.1987-10-01
KIRSCHNER NEER-III PROXIMAL HUMERUS (K873073)Kirschner Medical Corp.1987-10-01
URETERAL BULB DILATORS (K873178)Penn Medical Devices, Inc.1987-09-30
CHURCHILL INTER-CARDIAC SUCKER (K872043)Churchill Corp.1987-09-30
HIGH FREQUENCY LINEAR ARRAY (HFLA) SCANHEAD (K872068)Advanced Technology Laboratories, Inc.1987-09-30
SURE-STREP A TEST KIT CATALOG NO. MB-1083 (K872346)Medix Biotech, Inc.1987-09-30
FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT (K872166)Bd Becton Dickinson Vacutainer Systems Preanalytic1987-09-30
MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (K873206)Respiratory Support Products, Inc.1987-09-30
EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER (K872719)Shiley, Inc.1987-09-30
MODIFIED RADIUS - MODEL NUMBER MM 5000 (K871727)Ultrasonix, Inc.1987-09-30
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30 (K872596)American Edwards Laboratories1987-09-30
TENS LEAD (K873608)Desco Industries, Inc.1987-09-30
LIFESCOPE 12, BSM 8500A PATIENT MONITOR (K872241)Nihon Kohden America, Inc.1987-09-30
UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM (K872652)Travenol Laboratories, S.A.1987-09-30
OXFORD RETRO-ILLUMINATION CATARACT CAMERA (K873157)Holofax , Ltd.1987-09-30
NONPRESCRIPTION SUNGLASSES (K873685)Arcotoys, Inc.1987-09-30
LEUKOCLIP(R) (K873744)Beiersdorf, Inc.1987-09-30
A.R.M. (ASPEN RETURN MONITOR) (K873591)Qmed, Inc.1987-09-30
MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER (K870794)Nihon Kohden America, Inc.1987-09-30
OVAL PULL-APART SHEATH/DILATOR (K873394)Quinton, Inc.1987-09-30
LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA (K873186)Serono Diagnostics, Inc.1987-09-29
OPTI-ZYME(R) (K873548)Alcon Laboratories1987-09-29
SABOURAUD DEXTR/BHI SD/BHI AGAR SLT W/6% SHEEP BLD (K873320)Lakewood Biochemical Co., Inc.1987-09-29
U-IMPULSE AIR CONDUCTION IN-THE-CANAL HEARING AID (K873560)Richards Medical Co., Inc.1987-09-29
SABOUR DEXTR W/CHLORAMPHEN/GENTAM SD W/C&G AGAR PL (K873318)Lakewood Biochemical Co., Inc.1987-09-29
QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL (K873467)Quantimetrix Medical Industries1987-09-29
QTEST STREP (K872961)Quidel Corp.1987-09-29
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 (K873350)Em Diagnostic Systems, Inc.1987-09-29
SABOUR DEXTROSE/BHI SD/BHI AGAR SLT TUBE #T4300 (K873321)Lakewood Biochemical Co., Inc.1987-09-29
UTERINE INJECTOR 2MM (K873515)Zinnanti Surgical Instruments, Inc.1987-09-29
TELSTAR MODEL PP (K873210)Telstar Electronics, Inc.1987-09-29
G-GT STANDARD CALIBRATOR (K871759)Wako Chemicals USA, Inc.1987-09-29
TIF FECAL TEST (K873594)Devetec, Inc.1987-09-29
SPECTROPHOTOMETER (MICROASSAY PLATE READERS) (K873678)Slt Labinstruments, Inc.1987-09-29
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST (K872852)Sandare Chemical Co., Inc.1987-09-29
CUSTOM IN-THE-EAR HEARING AID SERIES MCA20 (K873468)Maico Hearing Instruments, Inc.1987-09-29
SABOUR DEXTR SD AGAR SLNT TUBE W/CHLORAMP #T3088 (K873322)Lakewood Biochemical Co., Inc.1987-09-29
ARTHROCOMBI 5003 (K871181)F.M. Wiest USA, Inc.1987-09-29
ARTHRO AUTOMAT 5002 (K871180)F.M. Wiest USA, Inc.1987-09-29
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 (K873681)Em Diagnostic Systems, Inc.1987-09-29
SPINOSCOPE (K872836)Diagnospine Fabrication, Inc.1987-09-29
ADMS TRANSRECTAL 7.5 MHZ PROBE (K870967)Diasonics, Inc.1987-09-29
MICRO-CHEM ANALYZER (K873638)Ocean Scientific, Inc.1987-09-29
SABOURAUD DEXTROSE (SD) W/CHLORAMP AGAR PLATE (K873319)Lakewood Biochemical Co., Inc.1987-09-29
STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY (K873171)American Dade1987-09-29
QBC VENOUS BLOOD CONTROL/MULTIPLE (K873354)R&D Systems, Inc.1987-09-29
SPERM-SELECT ADDITIONAL INDICATION (K872849)Pharmacia, Inc.1987-09-28
H-H HUNTER ACTIVE TENDON IMPLANT DC (K872285)Holter-Hausner Intl.1987-09-28
MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY (K872711)Directed Energy, Inc.1987-09-28
AUXILIARY CONTINUOUS WAVE DOPPLER TRANSDUCER (K871416)Acuson Computed Sonography1987-09-28
CEDAR(TM) RETRACTOR RING (K873691)Cedar Surgical, Inc.1987-09-28
H-H HUNTER ACTIVE TENDON IMPLANT BC (K872293)Holter-Hausner Intl.1987-09-28
ACUSON L538 TRANSDUCER (K871506)Acuson Computed Sonography1987-09-28
UNIVERSAL JET VENTILATOR MODEL AMS-1000 (K863155)Acutronic Medical Systems AG1987-09-28
H-H HUNTER ACTIVE TENDON IMPLANT PC (K872284)Holter-Hausner Intl.1987-09-28
MOUTH TO FACE RESUSCITATOR (K873043)Artec Environmental Monitoring Division1987-09-28
ARIES (K873170)Mountain Medical Equipment, Inc.1987-09-25
ESCORT PORTABLE PATIENT MONITOR (K872291)Medical Data Electronics1987-09-25
VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SER (K873035)Gish Biomedical, Inc.1987-09-25
MODIFIED CAROTID SHUNT W/SPRING REINFORCED LUMEN (K872788)Uresil Corp.1987-09-25
CYTOMEGALOVIRUS CONTROL SLIDES (K873114)Medical Diagnostic Technologies, Inc.1987-09-25
VAN DELLEN ASPIRATOR (K873462)Van Dellen, Ltd.1987-09-25
MODEL MICRO FD+ AMBULATORY ECG MONITOR (K872508)Advanced Medical Products, Inc.1987-09-25
DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 (K871970)Diagnostic Products Corp.1987-09-25
FAC GE1/HI PERF FAC UPR BODY TE2/FULL BODY GA 8-12 (K873430)Klafs Sunlight Corp.1987-09-25
MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM (K871711)Medical Graphics Corp.1987-09-25
PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA (K873400)Serono Diagnostics, Inc.1987-09-25
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 (K862970)Medtronic Vascular1987-09-25
VARIOUS TYPES OF: KEELER MAGNATONE 2 STETHOSCOPES: (K871369)Keeler Instruments, Inc.1987-09-24
NINJA SCALPEL (K873493)Primrose Medical, Inc.1987-09-24
INTELECT MODEL 575 (K872654)Chattanooga Group, Inc.1987-09-24
LACERATION AND INSTRUMENT TRAYS (K873290)Advantage Medical Systems, Inc.1987-09-24
97-D EMERSON DIMMER CONTROL (K872936)J. H. Emerson Co.1987-09-24
JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS (K873514)Johnson & Johnson Professionals, Inc.1987-09-24
97-TD EMERSON TIMER/DIMMER CONTROL (K872937)J. H. Emerson Co.1987-09-24
SKYTRON MODEL 130 SURGICAL TABLE (K873478)Skytron, Div. the Kmw Group, Inc.1987-09-24
TORAY ANTHRON AORTA BYPASS TUBES (K872762)Toray Industries (America), Inc.1987-09-24
MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT (K872710)Directed Energy, Inc.1987-09-24
CYBEX 340 (K872911)Cybex1987-09-24
BRAIN HEART INFUS AGAR W/5% SB & GENTAMICIN-#P3772 (K873224)Lakewood Biochemical Co., Inc.1987-09-23
EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR (K872721)Shiley, Inc.1987-09-23
MANNITOL SALT AGAR (MSA) PRODUCT #P1706 (K873227)Lakewood Biochemical Co., Inc.1987-09-23
HOWMEDICA PCA COLLARED FEMORAL STEM (K873458)Howmedica Corp.1987-09-23
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Every clearance here is in the API, with alerts when new ones post.