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
104905–104928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 10, 1995
CAT-600 PENILE PLETHYSMOGRAPH
K936115 · LIL
Farrall Instruments, Inc.
Gastroenterology & Urology · 690d
Cleared Jan 10, 1995
CAT-400UL PENILE PLETHYSMOGRAPH
K940128 · LIL
Farrall Instruments, Inc.
Gastroenterology & Urology · 365d
Cleared Jan 09, 1995
FLEXIFLO TUBE PLACEMENT VERIFIER
K922216 · KNT
Abbott Laboratories
Gastroenterology & Urology · 972d
Cleared Jan 09, 1995
RICHARDS TOTAL KNEE SYSTEM
K933958 · JWH
Smith & Nephew Richards, Inc.
Orthopedic · 514d
Cleared Jan 09, 1995
SWIMEX MULTIDEPTH POOL (MODEL 600T)
K935011 · BXB
Swimex Systems
Physical Medicine · 446d
Cleared Jan 09, 1995
LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100
K941870 · BTL
Life Support Products, Inc.
Anesthesiology · 266d
Cleared Jan 09, 1995
LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100
K941871 · BTL
Life Support Products, Inc.
Anesthesiology · 266d
Cleared Jan 09, 1995
INSYTE INTRODUCER CATHETER
K942045 · FOZ
Becton Dickinson Vascular Access, Inc.
General Hospital · 256d
Cleared Jan 09, 1995
MICRODILUTION/LORACARBEF PANELS
K942089 · JWY
Baxter Diagnostics, Inc.
Microbiology · 252d
Cleared Jan 09, 1995
DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE
K942267 · JWY
Baxter Diagnostics, Inc.
Microbiology · 244d
Cleared Jan 09, 1995
SILKON TITANIUM CABLE SYSTEM
K942300 · JDQ
American Medical Electronics, Inc.
Orthopedic · 242d
Cleared Jan 09, 1995
PARAMOUNT CEMENTED HIP STEM PROTHESIS
K942537 · JDI
Depuy, Inc.
Orthopedic · 227d
Cleared Jan 09, 1995
PLATO 3300/1300
K943454 · JJQ
Rosys, Inc.
Chemistry · 175d
Cleared Jan 09, 1995
IMAGEN
K943557 · GQS
Dako Diagnostics , Ltd.
Microbiology · 171d
Cleared Jan 09, 1995
STRYKER TOTAL PERFORMANCE SYSTEM
K943569 · ERL
Stryker Corp.
Ear, Nose, Throat · 171d
Cleared Jan 09, 1995
SUNGLASSES
K944568 · HQY
Great Field Industries Co., Ltd.
Ophthalmic · 112d
Cleared Jan 09, 1995
BLACKSTAR(TM) STAR SYSTEM
K945659 · ERL
Xomed-Treace, Inc.
Ear, Nose, Throat · 53d
Cleared Jan 09, 1995
POWER RANGERS SUNGLASSES
K945823 · HQY
Avon Products, Inc.
Ophthalmic · 41d
Cleared Jan 09, 1995
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE,...
K946173 · GAQ
Ethicon, Inc.
General & Plastic Surgery · 21d
Cleared Jan 06, 1995
INTRAUTERINE CATHETER AND INTRODUCER
K932993 · MFD
Conceptus, Inc.
Obstetrics & Gynecology · 567d
Cleared Jan 06, 1995
STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360
K936273 · HET
Baxter Healthcare Corp
Obstetrics & Gynecology · 388d
Cleared Jan 06, 1995
HORIZON 9000 WS
K940415 · DXG
Mennen Medical, Inc.
Cardiovascular · 343d
Cleared Jan 06, 1995
THE TITANIUM FIXATION SYSTEM
K943071 · JEY
Biomedics
Dental · 192d
Cleared Jan 06, 1995
P.F.C. TOTAL HIP SYSTEM
K944132 · KWY
Johnson & Johnson Professionals, Inc.
Orthopedic · 135d