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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

175,230 results

136201–136224 of 175,230

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

Cleared Mar 18, 1988

CUSTOM CANAL HEARING AIDS INTRA II CC-5, 6 & 7

Starkey Laboratories, Inc.

Ear, Nose, Throat · 52d

Cleared Mar 18, 1988

INTRA II SECRET EAR HEARING AIDS ISE

Starkey Laboratories, Inc.

Ear, Nose, Throat · 52d

Cleared Mar 18, 1988

SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH

Baxter Healthcare Corp

General Hospital · 42d

Cleared Mar 18, 1988

CLP 0.02 M CALCIUM CHLORIDE SOLUTION.

Creative Laboratory Products, Inc.

Hematology · 25d

Cleared Mar 18, 1988

CLP 0.1 M SODIUM CITRATE SOLUTION

Creative Laboratory Products, Inc.

Hematology · 25d

Cleared Mar 17, 1988

OPTEC 1000 DMV VISION TESTER MODIFY

Stereo Optical Co., Inc.

Ophthalmic · 86d

Cleared Mar 17, 1988

Gull Laboratories, Inc.

Microbiology · 73d

Cleared Mar 17, 1988

3 IN 1 AUTOMATIC TOURNIQUET

Systematics Mfg. & Tool Co., Inc.

General & Plastic Surgery · 72d

Cleared Mar 17, 1988

PATHFINDER(TM) DIRECT DETECTION SYS C. TRACHOMATIS

Kallestad Diag, A Div. of Erbamont, Inc.

Microbiology · 72d

Cleared Mar 17, 1988

THE STORZ BIPOLAR PENCIL AND CORD

Storz Instrument Co.

Neurology · 52d

Cleared Mar 17, 1988

IONOMETER E-HK AND ACCESSORIES

Smash Ent., Inc.

Hematology · 50d

Cleared Mar 17, 1988

POWER TOILET ELEVATOR

Physical Medicine · 48d

Cleared Mar 17, 1988

L-5 PLASTIC SURGERY CANNULAS

American Instrument Manufacturer'S, Inc.

General & Plastic Surgery · 28d

Cleared Mar 17, 1988

FLAT STICK SPONGE

Ormed Mfg., Inc.

General & Plastic Surgery · 16d

Cleared Mar 17, 1988

ROSEBUD DISSECTORS

Ormed Mfg., Inc.

General & Plastic Surgery · 16d

Cleared Mar 17, 1988

Ormed Mfg., Inc.

General & Plastic Surgery · 16d

Cleared Mar 17, 1988

STRUNG ABSORBENT BALLS

Ormed Mfg., Inc.

General & Plastic Surgery · 16d

Cleared Mar 17, 1988

MECHANICAL ADJUSTABLE CHAIR (AC POWERED)

Craftmatic/Contour Organization, Inc.

Physical Medicine · 16d

Cleared Mar 17, 1988

IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN

Baxter Healthcare Corp

Hematology · 16d

Cleared Mar 17, 1988

SONICATOR 710 (MODEL ME710)

Mettler Electronics Corp.

Physical Medicine · 15d

Cleared Mar 17, 1988

TRIANGLE SPONGE

Ormed Mfg., Inc.

General & Plastic Surgery · 14d

Cleared Mar 17, 1988

TRACHEOTOMY SPONGES

Ormed Mfg., Inc.

General & Plastic Surgery · 14d

Cleared Mar 17, 1988

ROUND STICK SPONGES

Ormed Mfg., Inc.

General & Plastic Surgery · 14d

Cleared Mar 17, 1988

Ormed Mfg., Inc.

General & Plastic Surgery · 14d