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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
90313–90336 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1998
CK-NAC REAGENT
K974833 · CGS
Intersect Systems, Inc.
Chemistry · 51d
Cleared Feb 13, 1998
IISYS PACS SYSTEM
K980220 · LMD
Sterling Diagnostic Imaging, Inc.
Radiology · 22d
Cleared Feb 12, 1998
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL
K972512 · LIT
Boston Scientific Scimed, Inc.
Cardiovascular · 220d
Cleared Feb 12, 1998
ACS TOBRAMYCIN
K974029 · LCR
Chiron Diagnostics Corp.
Toxicology · 112d
Cleared Feb 12, 1998
EPI-UNION PLATING SYSTEM
K974289 · HRS
Howmedica, Inc.
Orthopedic · 90d
Cleared Feb 12, 1998
OHMEDA-OHIO CARE PLUS INCUBATOR
K974349 · FMZ
Ohmeda Medical
General Hospital · 85d
Cleared Feb 12, 1998
PASCO MIC AND MIC/ID PANELS
K974362 · JWY
Pasco Laboratories, Inc.
Microbiology · 85d
Cleared Feb 12, 1998
SNORE-EZZER
K974531 · LRK
Snore - Ezzer
Dental · 72d
Cleared Feb 12, 1998
RANDOX MAGNESIUM
K974606 · JGJ
Randox Laboratories, Ltd.
Chemistry · 64d
Cleared Feb 12, 1998
FEMASSIST FLEXIBLE
K974645 · MNG
Insight Medical Corp.
Gastroenterology & Urology · 62d
Cleared Feb 12, 1998
ABBOTT AXSYM SYSTEM
K974651 · JJE
Abbott Laboratories
Chemistry · 66d
Cleared Feb 12, 1998
QUIKSTRIP ONE STEP BARBITURATE TEST
K974712 · DIS
Syntron Bioresearch, Inc.
Toxicology · 57d
Cleared Feb 12, 1998
NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
K974829 · LJT
Kawasumi Laboratories Co., Ltd.
General Hospital · 50d
Cleared Feb 12, 1998
BILIRUBIN-SL (TOTAL) ASSAY
K974874 · CIG
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 45d
Cleared Feb 12, 1998
KROMATICA COLOR CHANGING ALGINATE
K974894 · ELW
Matech, Inc.
Dental · 43d
Cleared Feb 12, 1998
VANISHPOINT SYRINGE
K980069 · MEG
Retractable Technologies, Inc.
General Hospital · 35d
Cleared Feb 12, 1998
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
K980178 · JJY
Bionostics, Inc.
Chemistry · 23d
Cleared Feb 12, 1998
2700 SAMPLE MANAGER
K980180 · JQW
Waters Corporation
Toxicology · 23d
Cleared Feb 12, 1998
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
K980205 · JHI
San Diego Biotech
Chemistry · 23d
Cleared Feb 12, 1998
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
K980316 · CJE
Diagnostic Chemicals , Ltd.
Chemistry · 16d
Cleared Feb 11, 1998
ENSEMBLE CENTRAL STATION MONITOR
K970358 · DSI
Mennen Medical, Inc.
Cardiovascular · 377d
Cleared Feb 11, 1998
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING
K971206 · LPH
Howmedica Corp.
Orthopedic · 336d
Cleared Feb 11, 1998
PHASED ARRAY TRANSDUCER - - PVF -375DT
K972771 · ITX
Toshiba America Medical Systems, In.C
Radiology · 202d
Cleared Feb 11, 1998
ULTRA-FINE DIATHERMY LOOP AND COAGULATION BALLS
K972856 · KNF
Rocket Medical Plc
Obstetrics & Gynecology · 194d