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
167089–167112 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 12, 1980
FERRIS BONE MARROW -NEEDLE-(DISPOSABLE)
K800407 · GAA
A.D.T. Lab Industries
General & Plastic Surgery · 15d
Cleared Mar 12, 1980
ADT MINI PERITONEAL LAVAGE KIT
K800422 · GBW
A.D.T. Lab Industries
General & Plastic Surgery · 15d
Cleared Mar 12, 1980
HEMOSTATIC/TUBE OCCLUDING FORCEPS
K800435 · GEN
Dravon Medical, Inc.
General & Plastic Surgery · 14d
Cleared Mar 12, 1980
SYRINGE TIP CONNECTOR
K800437 · KYX
Burron Medical Products, Inc.
General Hospital · 14d
Cleared Mar 12, 1980
DENTAL CAVITY VARNISH, CONCENTRATED
K800438 · LBH
Scientific Pharmaceuticals, Inc.
Dental · 13d
Cleared Mar 12, 1980
ADR COMPOSITE RESTORATIVE
K800439 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 13d
Cleared Mar 12, 1980
EDINBURGH MASKER
K800445 · KTH
Foundation For Fluency, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 12, 1980
GEMENI IGA ASSAY
K800449 · CZP
Electro-Nucleonics Laboratories, Inc.
Immunology · 12d
Cleared Mar 12, 1980
CENTRAL VENOUS PRESSURE CATHETER
K800461 · DQO
Medical Components, Inc.
Cardiovascular · 12d
Cleared Mar 12, 1980
STERILE DRESSING PACK
K800490 · KKX
Medi-Spec
General Hospital · 8d
Cleared Mar 12, 1980
THE LENS OR OMMI-GARD
K800521 · HQG
Gentex Corporation
Ophthalmic · 6d
Cleared Mar 10, 1980
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K792050 · FRN
3M Company
General Hospital · 150d
Cleared Mar 10, 1980
AMBLYOPIA TRAINER
K800112 · HPL
Life-Tech Instruments, Inc.
Ophthalmic · 54d
Cleared Mar 10, 1980
MICRONTA BP-1 ELECTRONIC B/P TESTER
K800225 · DXN
Tandy Corp.
Cardiovascular · 34d
Cleared Mar 10, 1980
MOIRE FRINGE VISOMETER AFTER LOTMAR
K800238 · HKL
Hagg-Streit Service, Inc.
Ophthalmic · 34d
Cleared Mar 10, 1980
0.45% SODIUM CHLORIDE SOL./RESP. THERAPY
K800294 · CAF
Abbott Laboratories
Anesthesiology · 28d
Cleared Mar 10, 1980
0.9% SODIUM CHLORIDE SOL./RESP. THERAPY
K800295 · CAF
Abbott Laboratories
Anesthesiology · 28d
Cleared Mar 10, 1980
DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI
K800318 · HBT
Edward Weck, Inc.
General & Plastic Surgery · 27d
Cleared Mar 10, 1980
PARKE-DAVIS TOTAL KNEE PROSTHESIS
K800363 · KTZ
Warner-Lambert Co.
Orthopedic · 19d
Cleared Mar 10, 1980
EARSCOPE
K800365 · ERA
Nash & Assoc.
Ear, Nose, Throat · 19d
Cleared Mar 10, 1980
MICRESURGICAL TRAY, SM.,MED., & LG.
K800367 · FSM
Edward Weck, Inc.
General & Plastic Surgery · 19d
Cleared Mar 10, 1980
ELLIK BLADDER EVACUATOR
K800397 · KQT
Sage Products, Inc.
Gastroenterology & Urology · 13d
Cleared Mar 10, 1980
VARIOTHERM
K800442 · ETP
Jedmed Instrument Co.
Ear, Nose, Throat · 11d
Cleared Mar 10, 1980
HYGROTHERM
K800443 · ETP
Jedmed Instrument Co.
Ear, Nose, Throat · 11d