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

70609–70632 of 175,468

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

Cleared Oct 15, 2003

Sybron Dental Specialties, Inc.

Cleared Oct 15, 2003

GENESIS II POROUS PLUS HA KNEE SYSTEM

Smith & Nephew, Inc.

Orthopedic · 47d

Cleared Oct 15, 2003

PRE-POWDERED, NON-STERILE, VINYL EXAM GLOVES, YELLOW

Shanghai Jiawang Industrial Co. , Ltd.

General Hospital · 37d

Cleared Oct 15, 2003

C.T.M. MOBILITY SCOOTER, MODEL HS-250

C.T.M. Homecare Product, Inc.

Physical Medicine · 23d

Cleared Oct 15, 2003

Medtronic Vascular

Cardiovascular · 23d

Cleared Oct 15, 2003

MODIFICATION TO: HORIZON 9000WS

Mennen Medical , Ltd.

Cardiovascular · 20d

Cleared Oct 15, 2003

MEDELA CLARIO HOME CARE PUMP

General & Plastic Surgery · 14d

Cleared Oct 14, 2003

Physical Medicine · 127d

Cleared Oct 14, 2003

Cortechs Labs, Inc.

Radiology · 89d

Cleared Oct 14, 2003

ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE)

ACON Laboratories, Inc.

Chemistry · 47d

Cleared Oct 14, 2003

REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139

Immunology · 29d

Cleared Oct 14, 2003

ACUCAM CONCEPT IV FWT, MODEL 110-0185G1

Cleared Oct 14, 2003

PRECISET DAT AMPHETAMINE CALIBRATORS

Roche Diagnostics Corp.

Chemistry · 14d

Cleared Oct 14, 2003

COBAS INTEGRA ALP IFCC GEN.2

Roche Diagnostics Corp.

Chemistry · 13d

Cleared Oct 14, 2003

EKOS PERIPHERAL INFUSION SYSTEM

Cardiovascular · 11d

Cleared Oct 10, 2003

INSIGHT MILLENNIUM III

Neurology · 379d

Cleared Oct 10, 2003

Biolase Technology, Inc.

General & Plastic Surgery · 232d

Cleared Oct 10, 2003

OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275

Ctf Systems (2001), Inc.

Neurology · 214d

Cleared Oct 10, 2003

CLUED UP MULTIPURPOSE SOLUTION- NO RUB

Clued UP Limited

Ophthalmic · 200d

Cleared Oct 10, 2003

MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300

Healthonics, Inc.

Physical Medicine · 193d

Cleared Oct 10, 2003

Cardiovascular · 177d

Cleared Oct 10, 2003

MODEL 2100 PULSE OXIMETER

Dolphin Medical, Inc.

Anesthesiology · 155d

Cleared Oct 10, 2003

ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01

Orthopedic · 154d

Cleared Oct 10, 2003

ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL

Orion Diagnostica, Div. Orion Corp.

Immunology · 141d