Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×

176,076 results

82873–82896 of 176,076

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

Cleared Jun 13, 2000

EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION

Cybercare, Inc.

Cardiovascular · 138d

Cleared Jun 13, 2000

SCANDINAVIAN IVF SCIENCES AB, HYBASE-1

Vitrolife AB/Scandinavian Ivf...

Obstetrics & Gynecology · 117d

Cleared Jun 13, 2000

CERAMIX EZ CAST, CERAMIX EZ CAST SOLDER, CERAMIX EZ CAST FLUX

Cleared Jun 13, 2000

DIGITAL INTEGRATION SYSTEM, DIS2000

Wellington Medical Systems, Inc.

Radiology · 76d

Cleared Jun 13, 2000

IVC THREE BLASTOCYST MEDIUM, CAT # 2007

Invitrocare, Inc.

Obstetrics & Gynecology · 68d

Cleared Jun 13, 2000

HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250

Kay See Dental Mfg. Co.

Cleared Jun 13, 2000

NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON

Ocular Concepts, LLC

Ophthalmic · 48d

Cleared Jun 13, 2000

HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100...

Pwa Industries Sdn. Bhd.

General Hospital · 33d

Cleared Jun 13, 2000

HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES

Pwa Industries Sdn. Bhd.

General Hospital · 32d

Cleared Jun 13, 2000

METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS...

Medvice Consulting, Inc.

Ophthalmic · 22d

Cleared Jun 13, 2000

METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR...

Metro Optics of Austin, Inc.

Ophthalmic · 19d

Cleared Jun 13, 2000

PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM

Pulsion Medical Systems, Inc.

Cardiovascular · 4d

Cleared Jun 13, 2000

VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC...

Baxter Healthcare Corp

General Hospital · 320d

Cleared Jun 12, 2000

DORNIER MEDILAS D SKINPULSE

Dornier Surgical Products, Inc.

General & Plastic Surgery · 154d

Cleared Jun 12, 2000

THE DAYA SYPHILIS TEST/THE TRUST ANTIGEN TEST

Beacon Biologicals, Inc.

Microbiology · 104d

Cleared Jun 12, 2000

MAXHEALTH WHEELCHAIR, MODEL HE-8631, HE-8621, HE-8651

Maxhealth Corp.

Physical Medicine · 54d

Cleared Jun 12, 2000

STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM

Medtronic Surgical Navigation...

Neurology · 52d

Cleared Jun 12, 2000

EUDERMIC PF POWDER-FREE SURGICAL GLOVES

Maxxim Medical, Inc.

General Hospital · 46d

Cleared Jun 12, 2000

'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE...

Genzyme Surgical Product (Genzyme...

General & Plastic Surgery · 35d

Cleared Jun 12, 2000

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING...

Perusahaan Getah Asas Sdn. Bhd.

General Hospital · 26d

Cleared Jun 12, 2000

PINNACLE ACETABULAR SYSTEM

DePuy Orthopaedics, Inc.

Orthopedic · 26d

Cleared Jun 12, 2000

MULTIPLE PRIVATE LABELS, NITRILE EXAM GLOVES, POWDER-FREE (WHITE)

Shanghai Poseidon Plastic Products...

General Hospital · 25d

Cleared Jun 12, 2000

3.5 MM LAPAROSCOPE (LG100, LG103)

Surgical Image Laboratories, Inc.

General & Plastic Surgery · 20d

Cleared Jun 12, 2000

SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM

Orthopedic · 252d