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

93025–93048 of 175,468

Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery

Cleared Aug 01, 1997

UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)

Gastroenterology & Urology · 64d

Cleared Aug 01, 1997

Ear, Nose, Throat · 57d

Cleared Aug 01, 1997

CRP-LEX SYSTEM: C-REACTIVE PROTEIN ANTIGEN DETECTION IN SERUM: SLIDE...

Trinity Laboratories, Inc.

Immunology · 53d

Cleared Aug 01, 1997

DRIED GRAM-NEGATIVE MIC/COMBO PANELS

Dade Microscan, Inc.

Microbiology · 52d

Cleared Aug 01, 1997

ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING...

Zhermack S.P.A.

Cleared Aug 01, 1997

INNOFLUOR GENTAMICIN ASSAY SYSTEM

Oxis Intl., Inc.

Toxicology · 39d

Cleared Aug 01, 1997

QUICKSTICK ONE STEP HCG PREGNANCY TEST

Chemistry · 15d

Cleared Aug 01, 1997

MODIFICATION OF EST CULTURE SYSTEM II - MYCO

Accumed Intl., Inc.

Microbiology · 63d

Cleared Jul 31, 1997

BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT...

Benz Research and Development Corp.

Ophthalmic · 335d

Cleared Jul 31, 1997

BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT...

Benz Research and Development Corp.

Ophthalmic · 317d

Cleared Jul 31, 1997

TMS COMFORT SERIES NASAL CPAP MASK

Tiara Medical Systems, Inc.

Anesthesiology · 293d

Cleared Jul 31, 1997

INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR

Intuitive Surgical, Inc.

General & Plastic Surgery · 227d

Cleared Jul 31, 1997

MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS

Boston Scientific Corp

Cardiovascular · 191d

Cleared Jul 31, 1997

EVT EXPANDABLE SHEATH

Guidant Cardiac and Vascular Surgery

Cardiovascular · 174d

Cleared Jul 31, 1997

AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM

Aeroquip Medical Products

General Hospital · 161d

Cleared Jul 31, 1997

ENDOSCOPIC VENTRICULAR CATHETER

Integra Neurocare, LLC

Neurology · 90d

Cleared Jul 31, 1997

APOLLO KNEE FEMORAL SPACERS

Sulzer Orthopedics, Inc.

Orthopedic · 79d

Cleared Jul 31, 1997

IVALON PVA SURGICAL SPEAR, IVALON EYE DRAIN, 80CC, IVALON EYE DRAIN, 400CC,...

M-Pact Worldwide Management Corp.

Ophthalmic · 73d

Cleared Jul 31, 1997

MEDIVISION ARTHROSCOP

Medivision Scope Service Center, Inc.

Orthopedic · 62d

Cleared Jul 31, 1997

VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000)

Advanced Care Medical Products

Gastroenterology & Urology · 57d

Cleared Jul 31, 1997

ALTERNATING PRESSURE AIR FLOTATION MATTRESS

Decubiti Concepts, Inc.

General Hospital · 52d

Cleared Jul 31, 1997

HAND HELD MEDISPACER

Thayer Medical Corp.

Anesthesiology · 91d

Cleared Jul 31, 1997

AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGC

Ear, Nose, Throat · 31d

Cleared Jul 31, 1997

NEVADA EYEWORKS, LUIGI LANATTA SUNGLASSES

Ophthalmic · 20d