FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
135073–135096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1988
MODEL 700 PATIENT MONITOR
K882118 · DRS
Ivy Biomedical Systems, Inc.
Cardiovascular · 75d
Cleared Aug 02, 1988
PANAMEX(TM) URETERAL STENT
K882157 · FAD
Kingston Technologies, Inc.
Gastroenterology & Urology · 71d
Cleared Aug 02, 1988
MEDIBLEND (TM) CLINICAL BLOOD GAS MIXTURES
K882209 · CHL
Linde Div. Union Carbide Corp.
Chemistry · 68d
Cleared Aug 02, 1988
CALIBRATION KIT
K882220 · JIW
King Diagnostics, Inc.
Chemistry · 68d
Cleared Aug 02, 1988
D-CHEM
K882307 · JJE
Photec Diagnostics, Inc.
Chemistry · 60d
Cleared Aug 02, 1988
TELEMETRIC STETHOSCOPE
K882319 · BZT
Vital Signs, Inc.
Anesthesiology · 57d
Cleared Aug 02, 1988
MODEL #825 ADULT STIM. PADS POLYMER TYPE
K882337 · LDD
Cardiotronics, Inc.
Cardiovascular · 57d
Cleared Aug 02, 1988
KOTEX LIGHTDAYS LONGS DEODORANT & REG. PANTILINERS
K882364 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 55d
Cleared Aug 02, 1988
RHYTHMSCAN HR HOLTER RECORDER
K882366 · DSH
Brentwood Instruments, Inc.
Cardiovascular · 55d
Cleared Aug 02, 1988
RESUBMITTED DIODE LASER COAGULATOR
K882372 · HQF
CooperVision, Inc.
Ophthalmic · 68d
Cleared Aug 02, 1988
DIAZO, COLORIMETRIC BILIRUBIN
K882459 · CIG
Tech-Neal Scientific, Inc.
Chemistry · 48d
Cleared Aug 02, 1988
ENZYMATIC CO2 REAGENT SET
K882497 · KHS
American Monitor Corp.
Chemistry · 46d
Cleared Aug 02, 1988
EMIT HVA AMPHETAMINE ASSAY
K882589 · DKZ
Syva Co.
Toxicology · 40d
Cleared Aug 02, 1988
TISSUE PUNCH
K882834 · EKJ
Tri-Stage, Inc.
Dental · 25d
Cleared Aug 02, 1988
WHEELCHAIR BCW 6000
K883034 · IOR
O'Tec Corp.
Physical Medicine · 14d
Cleared Aug 02, 1988
COMFORT CATH MALE EXTERNAL CATHETER
K883057 · EYT
Sierra Laboratories, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 02, 1988
VPI NON-ADHESIVE CONDOM CATHETER
K883119 · EYT
Cook Urological, Inc.
Gastroenterology & Urology · 8d
Cleared Aug 01, 1988
ACUTRON
K880042 · GZJ
Davis Assoc.
Neurology · 209d
Cleared Aug 01, 1988
MODEL 130YZ CO2-YAG SURGICAL LASER SYSTEM
K880816 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 166d
Cleared Aug 01, 1988
CAPTIA TOXO-G
K880918 · LGD
Mercia Diagnostics , Ltd.
Microbiology · 150d
Cleared Aug 01, 1988
THE LAITINEN STEREOTACTIC SYSTEM
K881131 · HAW
Sandstrom Trade & Technology, Inc.
Neurology · 138d
Cleared Aug 01, 1988
ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT
K881932 · GQH
Ortho Diagnostic Systems, Inc.
Microbiology · 83d
Cleared Aug 01, 1988
BIO-RAD HEMOGLOBIN DETECTOR
K882051 · LCP
Bio-Rad
Hematology · 77d
Cleared Aug 01, 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · LCP
Bio-Rad
Hematology · 67d