FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
147169–147192 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1985
ELECTROSURGICAL LATERAL RELEASE PROBE MOD ALR-100
K852683 · GEI
American Bentley
General & Plastic Surgery · 48d
Cleared Aug 12, 1985
VISIDEX II REAGENT STRIPS
K852747
Miles Laboratories, Inc.
Chemistry · 46d
Cleared Aug 12, 1985
CEFTAZIDIME 30 MCG SENSITVITY DISCS
K852835 · JTN
Difco Laboratories, Inc.
Microbiology · 41d
Cleared Aug 12, 1985
METALLIC SUNGLASSES
K852902 · HQY
Yours Enterprise Co., Ltd.
Ophthalmic · 34d
Cleared Aug 12, 1985
ENDAB PHENOBARBITAL
K852995 · DLZ
Immunotech Corp.
Toxicology · 28d
Cleared Aug 12, 1985
TRIGLYCERIDES LCK 124
K853041 · CDF
German American Chamber of Commerce,...
Chemistry · 24d
Cleared Aug 12, 1985
CITREX I
K853076 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CITREX II
K853077 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
CITREX III
K853078 · JPA
Bio/Data Corp.
Hematology · 20d
Cleared Aug 12, 1985
TD TRICYCLIC ANTIDEPRESSANTS
K853113 · LFG
Abbott Laboratories
Toxicology · 19d
Cleared Aug 12, 1985
MALIS BIPOLAR PEN
K853168 · GEI
Valley Forge Scientific Corp.
General & Plastic Surgery · 13d
Cleared Aug 12, 1985
ULTRACLONE ECL-01-2200 CELL LINE
K853203 · KIR
Earl-Clay Laboratories, Inc.
Pathology · 13d
Cleared Aug 12, 1985
TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
K853244 · CEK
Simmler, Inc.
Chemistry · 11d
Cleared Aug 09, 1985
RADI-BIOPSY DEVICE
K850605 · KNW
Radiplast AB
Gastroenterology & Urology · 175d
Cleared Aug 09, 1985
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD
K851897 · DTD
Cardiac Control Systems, Inc.
Cardiovascular · 101d
Cleared Aug 09, 1985
MECTA ECT DEVICE MODELS SR & JR
K852069 · QGH
Mecta Corp.
Neurology · 91d
Cleared Aug 09, 1985
CAPIOX BLOOD SAMPLING MANIFOLD
K852086 · DTL
Terumo Medical Corp.
Cardiovascular · 88d
Cleared Aug 09, 1985
BARD-PARKER IRRIGATION CATHETER
K852099 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 86d
Cleared Aug 09, 1985
FOAM ECG ELECTRODES
K852177 · DRX
Clinical Data, Inc.
Cardiovascular · 81d
Cleared Aug 09, 1985
BELIEVE LABIAL PADS
K852226 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 79d
Cleared Aug 09, 1985
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
K852232 · DXS
Dlp, Inc.
Cardiovascular · 79d
Cleared Aug 09, 1985
CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRATOR, 9001
K852271 · HQE
CooperVision, Inc.
Ophthalmic · 73d
Cleared Aug 09, 1985
KIRSCHNER SELF-TAPPING ACETABULAR CUP
K852351 · KWA
Kirschner Medical Corp.
Orthopedic · 70d
Cleared Aug 09, 1985
MIC GASTROSTOMY TUBE PERCUTANEOUS INSERTION KIT
K852363 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 66d