FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
94561–94584 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 27, 1997
POINT OF USE II SHARPS-A-GATOR
K964387 · MMK
Graphic Controls Corp.
General Hospital · 143d
Cleared Mar 27, 1997
TEETHMATE F-1
K965091 · EBC
Kuraray Company, Ltd.
Dental · 98d
Cleared Mar 27, 1997
NIPRO DISPOSABLE SOLUTION INFUSION SET
K970076 · FPA
Nipro Medical Corp.
General Hospital · 77d
Cleared Mar 27, 1997
JIAWANG POWDER-FREE VINYL EXAMINATION GLOVES
K970111 · LYZ
Shanghai Jiawang Industrial Co. , Ltd.
General Hospital · 73d
Cleared Mar 27, 1997
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
K970433 · ELW
Dentsply Intl.
Dental · 50d
Cleared Mar 27, 1997
EKONIC DENTAL/MEDICAL MASK (MD 610)
K970440 · FXX
Ekonic Company, Ltd.
General Hospital · 50d
Cleared Mar 27, 1997
POLY-MED
K970625 · LYY
Shinemound Enterprise, Inc.
General Hospital · 36d
Cleared Mar 27, 1997
PNEUMO-MATIC INSUFFLATION NEEDLE
K970788 · FHO
Apple Medical Corp.
Gastroenterology & Urology · 23d
Cleared Mar 27, 1997
CONVERTORS IMPERVIOUS SHOE COVERS
K970815 · FXP
Allegiance Healthcare Corp.
General Hospital · 21d
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