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

Filters: Cleared only ×
175,820 results
125329–125352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 17, 1990
PARKER MICROPUMP MODEL 2100
K902309 · FRN
Chathamborough Research Group, Inc.
General Hospital · 86d
Cleared Aug 17, 1990
MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER
K902370 · FAH
Boston Scientific Corp
Gastroenterology & Urology · 80d
Cleared Aug 17, 1990
PENLON BREATHING SYSTEM PRESSURE MONITOR
K902381 · CAP
Penlon, Inc.
Toxicology · 79d
Cleared Aug 17, 1990
PHILIPS INTEGRIS C2000 SYSTEM
K902542 · IZI
Philips Medical Systems North...
Radiology · 72d
Cleared Aug 17, 1990
XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM
K902557 · JAK
Toshiba America Medical Systems, In.C
Radiology · 67d
Cleared Aug 17, 1990
COLLAGEN SHIELD FOR ACUTE CARE
K902558 · MOE
Vitaphore Corp.
Ophthalmic · 67d
Cleared Aug 17, 1990
I.C. MEDICAL SMOKE EVACUATOR ACTIVATOR
K902611 · FYD
I.C Medical, Inc.
General Hospital · 65d
Cleared Aug 17, 1990
PINNACLE IMAGE PROCESSING SYSTEM
K902648 · LLZ
Medasys, Inc.
Radiology · 63d
Cleared Aug 17, 1990
STERI-SHIELD
K902677 · FXY
Biomedical Devices, Inc.
General Hospital · 60d
Cleared Aug 17, 1990
KODAK X-OMAT 460 RA PROCESSOR
K902732 · IXW
Eastman Kodak Company
Radiology · 57d
Cleared Aug 17, 1990
SUCTION CATHETER, STERILE
K902814 · BSY
Orion Life Systems, Inc.
Anesthesiology · 50d
Cleared Aug 17, 1990
MILENIA(TM) PCP
K902960 · LCM
Diagnostic Products Corp.
Toxicology · 43d
Cleared Aug 17, 1990
EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS
K903152 · DKB
Syva Co.
Toxicology · 30d
Cleared Aug 17, 1990
MONI-TROL XL AND L UNASSAYED LIQUID CHEMISTRY
K903190 · JJY
Medical Analysis Systems, Inc.
Chemistry · 29d
Cleared Aug 17, 1990
ASPARTATE AMINOTRANSFERASE TEST
K903197 · CIT
Em Diagnostic Systems, Inc.
Chemistry · 29d
Cleared Aug 17, 1990
CHALLENGE BRAND LIQUID MULTI-ENZYME LINEARITY CONT
K903225 · JJY
Medical Analysis Systems, Inc.
Chemistry · 25d
Cleared Aug 17, 1990
EMIT ETS PLUS ETHYL ALCOHOL ASSAY
K903228 · DMI
Syva Co.
Toxicology · 25d
Cleared Aug 17, 1990
MODEL 900S APNEA/HEART MONITOR
K903287 · BZQ
Healthdyne, Inc.
Anesthesiology · 37d
Cleared Aug 17, 1990
SYNERMED CREATININE REAGENT KIT
K903296 · CGX
Synermed, Inc.
Chemistry · 24d
Cleared Aug 17, 1990
TEMP MARQ TEMPERATURE TREND INDICATOR
K903307 · KPD
Marquest Medical Products, Inc.
General Hospital · 24d
Cleared Aug 17, 1990
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K903319 · LNH
GE Medical Systems
Radiology · 23d
Cleared Aug 17, 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332 · JFJ
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
CREATINE KINASE TEST (CK) ITEM NUMBER 65411
K903333 · CGS
Em Diagnostic Systems, Inc.
Chemistry · 23d
Cleared Aug 17, 1990
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
K903335 · CDO
Em Diagnostic Systems, Inc.
Chemistry · 23d