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
94057–94080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 26, 1997
MAGNO ALARM
K960849 · DTG
Cardiac Assist Devices, Inc.
Cardiovascular · 400d
Cleared Mar 26, 1997
LEVEL 10 HDI
K961459 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 344d
Cleared Mar 26, 1997
MODEL 8800 ASPIRATOR
K963775 · BTA
Medical Specifics, Inc.
General & Plastic Surgery · 188d
Cleared Mar 26, 1997
DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM
K964024 · KWP
Depuy, Inc.
Orthopedic · 170d
Cleared Mar 26, 1997
BACFIX SPINAL FIXATION SYSTEM
K964404 · KWP
Spinal Concepts, Inc.
Orthopedic · 142d
Cleared Mar 26, 1997
ORBSHOT KERATOMETER
K964891 · MMQ
Orbtek, Inc.
Ophthalmic · 110d
Cleared Mar 26, 1997
MAGNESIUM
K964915 · JGJ
Derma Media Lab., Inc.
Chemistry · 107d
Cleared Mar 26, 1997
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K965129 · LSR
Wampole Laboratories
Microbiology · 93d
Cleared Mar 26, 1997
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K965131 · LSR
Wampole Laboratories
Microbiology · 93d
Cleared Mar 26, 1997
AIR CONDUCTION ASSISTIVE LISTENING DEVICE.PERSONAL AMPLIFIER
K970340 · LZI
Bellab
Ear, Nose, Throat · 56d
Cleared Mar 26, 1997
DOCTORS REVIEW SYSTEM
K970402 · LLZ
Digisonics, Inc.
Radiology · 51d
Cleared Mar 26, 1997
WIDEX SENSO DIGITAL (CIC)
K970904 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 14d
Cleared Mar 25, 1997
SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTION
K962970 · DSI
Spacelabs Medical, Inc.
Cardiovascular · 237d
Cleared Mar 25, 1997
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
K963203 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 222d
Cleared Mar 25, 1997
SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM
K963325 · HRS
Synthes (Usa)
Orthopedic · 214d
Cleared Mar 25, 1997
AVANTA ORTHOPAEDICS TENDON SPACER
K964359 · HXA
Avanta Orthopaedics, Inc.
Orthopedic · 144d
Cleared Mar 25, 1997
THE C-FIT FEMORAL HIP SYSTEM
K965019 · JDI
Corin USA
Orthopedic · 99d
Cleared Mar 25, 1997
MENICON Z BIFOCAL DESIGN LENS/MENICON Z TRIFOCAL DESIGN LENS
K970019 · LPL
Menicon U.S.A., Inc.
Ophthalmic · 82d
Cleared Mar 25, 1997
FIXATION PIN OR ROD
K970036 · HTY
United States Surgical, A Division of...
Orthopedic · 81d
Cleared Mar 25, 1997
EXTRACTORRX
K970052 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 77d
Cleared Mar 25, 1997
INNOVASIVE 2.8MM AND 3.5MM ROC LF SUTURE BONE FASTENER
K970089 · MBI
Innovasive Devices, Inc.
Orthopedic · 74d
Cleared Mar 25, 1997
HEDGES CORNEAL WETTING PAK
K970161 · KYG
Hedges Cwp, Inc.
Ophthalmic · 70d
Cleared Mar 25, 1997
IRRIGATION/ASPIRATION POLYPECTOMY
K970356 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 54d
Cleared Mar 25, 1997
VICTORY EYEWEAR CO
K970538 · HQY
Victory Eyewear Co., Ltd.
Ophthalmic · 41d