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
163321–163344 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1981
EXP 200 PARALLEL PLATE DIALYZER
K811439 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 21d
Cleared Jun 12, 1981
EXP 600 PARALLEL PLATE DIALYZER
K811440 · FJG
Extracorporeal Medical Specialities,...
Gastroenterology & Urology · 21d
Cleared Jun 12, 1981
HYDRON WOUND DRESSING KIT
K811446 · KMF
National Patent Development Corp.
General & Plastic Surgery · 21d
Cleared Jun 12, 1981
ORTHO-FRAC KIT
K811456 · IQI
Orthomedics
Physical Medicine · 21d
Cleared Jun 12, 1981
AUTO-SYRINGE MICRO VOLUME EXTENSION SET
K811463 · FPA
Baxter Healthcare Corp
General Hospital · 17d
Cleared Jun 12, 1981
IMIPRAMINE/DISIPRAMINE/LITHIUM
K811465 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
AMITRIPTYLINE/NORTRIPTYLINE/LITHIUM
K811466 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
DOXEPIN/DESMETHLDOXEPIN/LITHIUM
K811467 · JJY
Ortho Diagnostic Systems, Inc.
Chemistry · 17d
Cleared Jun 12, 1981
MMG URINARY DRAINAGE TUBING
K811469 · KNX
Medical Marketing Group
Gastroenterology & Urology · 17d
Cleared Jun 12, 1981
LIFESPAN 100
K811470 · KLK
Biochem International, Inc.
Anesthesiology · 17d
Cleared Jun 12, 1981
BOOK HOLDER
K811487 · ILP
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
FEEDING AID KIT
K811488 · ILC
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
SCOOTER BOARD
K811489 · KNL
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
FOREARM & KNEE STRAPS
K811490 · IQI
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
WHEELCHAIR ACCESSORIES
K811491 · KNO
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
DRESSING ADAPTORS
K811492 · ILD
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
CRUTCH & WALKER PADS
K811493 · INP
Fred Sammons, Inc.
Physical Medicine · 17d
Cleared Jun 12, 1981
MODELS TA 1017 & 1017T GRITIFLO DISPOS
K811538 · DRS
Gould, Inc.
Cardiovascular · 11d
Cleared Jun 11, 1981
OPTOCRYL CONTACT LENS BLANKS
K810130 · HPX
Optacryl, Inc.
Ophthalmic · 143d
Cleared Jun 11, 1981
MODELS: 52-01-0, 52-01-1
K811110 · FPA
Y
General Hospital · 49d
Cleared Jun 09, 1981
OFFENBACK REVERSIBLE BARIUM PUMP
K803183 · FRN
The Offenback Co.
Radiology · 175d
Cleared Jun 09, 1981
CELL DYN 800 HEMATOLOGY ANALYZER
K803218 · GKL
Abbott Diagnostics
Hematology · 173d
Cleared Jun 09, 1981
COBE PPD .8
K810066 · FJG
Cobe Laboratories, Inc.
Gastroenterology & Urology · 147d
Cleared Jun 09, 1981
ULTRAPROBE
K810133 · IYN
Ars Magna
Radiology · 141d