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
70753–70776 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 13, 2003
CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION
K032370 · DSI
Ge Medical Systems Information...
Cardiovascular · 12d
Cleared Aug 12, 2003
EVOLVE CERAMIC RADIAL HEAD IMPLANT
K030384 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 188d
Cleared Aug 12, 2003
XIVE 3.0 DENTAL IMPLANT SYSTEM
K030639 · DZE
Friandent GmbH
Dental · 165d
Cleared Aug 12, 2003
STRYKER VISUM SURGICAL LIGHTING SYSTEM
K031068 · FSY
Stryker Endoscopy
General & Plastic Surgery · 130d
Cleared Aug 12, 2003
IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX,...
K031106 · DZE
Imtec Corp.
Dental · 126d
Cleared Aug 12, 2003
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
K031331 · FGE
Abbott Vascular, Inc.
Gastroenterology & Urology · 106d
Cleared Aug 12, 2003
AUDIOMETER, OTOACOUSTIC EMISSION, AUDITORY BRANSTEM RESPONSE ACCESS
K031713 · EWO
Viasys Healthcare, Inc.
Ear, Nose, Throat · 71d
Cleared Aug 12, 2003
CI TKR/UKR
K031770 · HAW
Brainlab AG
Neurology · 64d
Cleared Aug 12, 2003
PVS 1300 SYNCHRO 0.014 & PVS 1600 SYNCHRO 0.010 GUIDE WIRES
K032146 · DQX
Precision Vascular Systems, Inc.
Cardiovascular · 29d
Cleared Aug 12, 2003
CRYOCARE CS SURGICAL SYSTEM
K032333 · GEH
Endocare, Inc.
Radiology · 14d
Cleared Aug 12, 2003
ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL
K032367 · HSB
Zimmer, Inc.
Orthopedic · 11d
Cleared Aug 11, 2003
BOWIE-DICK MINI PAK, MODEL BD 115
K024293 · JOJ
Steritec Products, Inc.
General Hospital · 230d
Cleared Aug 11, 2003
MALLORY/HEAD TOTAL HIP SYSTEM
K030055 · LPH
Biomet, Inc.
Orthopedic · 217d
Cleared Aug 11, 2003
DEROYAL SURGICAL DRAPES BACKTABLE COVER
K030908 · KKX
Deroyal
General Hospital · 140d
Cleared Aug 11, 2003
LED HEADLIGHT
K031548 · FSR
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Aug 11, 2003
SOLID STATE LAMP [LED] HEADLIGHT
K031549 · FSR
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Aug 11, 2003
RAMSOFT PACS, MODEL 3.0
K031562 · LLZ
Ramsoft, Inc.
Radiology · 84d
Cleared Aug 11, 2003
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
K031636 · DSP
Datascope Corp.
Cardiovascular · 76d
Cleared Aug 11, 2003
ULTRASITE VALVE
K031923 · FPA
B.Braun Medical, Inc.
General Hospital · 49d
Cleared Aug 11, 2003
POLY Q (GARANT L, PENTA M, PENTA H)
K032001 · ELW
3M Espe AG Dental Products
Dental · 45d
Cleared Aug 11, 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · HWC
Walter Lorenz Surgical, Inc.
Orthopedic · 21d
Cleared Aug 11, 2003
CD HORIZON SPINAL SYSTEM
K032265 · KWQ
Medtronic Sofamor Danek
Orthopedic · 19d
Cleared Aug 08, 2003
VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1
K024359 · MYU
Vista Scientific, LLC
Neurology · 221d
Cleared Aug 08, 2003
ELECTROPHYSIOLOGY CATHETER
K030109 · NLH
Alliance Medical Corp.
Cardiovascular · 207d