FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90817–90840 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 13, 1998
HEALTHCARE SERVICE AND SUPPLY ALP ALTERNATING LEG PRESSURE PUMP AND GAARMENTS...
K974318 · JOW
Healthcare Service and Supply
Cardiovascular · 88d
Cleared Feb 13, 1998
EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
K974335 · DXE
J-Lloyd Medical, Inc.
Cardiovascular · 87d
Cleared Feb 13, 1998
CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.
K974336 · GCJ
J-Lloyd Medical, Inc.
General & Plastic Surgery · 87d
Cleared Feb 13, 1998
MITEK KNOTLESS ANCHOR
K974345 · MBI
Mitek Products
Orthopedic · 86d
Cleared Feb 13, 1998
ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING
K974348 · FRO
Laboratoires Urgo S.A.
General & Plastic Surgery · 86d
Cleared Feb 13, 1998
ADVANTX LCN, ADVANTX LCLP
K974367 · IZI
GE Medical Systems
Radiology · 85d
Cleared Feb 13, 1998
EXPERT-XL LATERAL SPINE BMD ACQUISITION AND ANALYSIS SOFTWARE
K974437 · KGI
Lunar Corp.
Radiology · 81d
Cleared Feb 13, 1998
NUMASTATION
K974444 · KPS
Numa, Inc.
Radiology · 80d
Cleared Feb 13, 1998
ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
K974779 · JJE
Abbott Laboratories
Chemistry · 53d
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