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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×

174,955 results

117001–117024 of 174,955

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

Cleared Jun 04, 1992

Q-MS NEUROMUSCULAR STIMULATOR

Quantitative Medicine, Inc.

Physical Medicine · 366d

Cleared Jun 04, 1992

SMITH & NEPHEW DYONICS TMJ ARTHROSCOPY INFLOW SET

Smith & Nephew Dyonics, Inc.

Orthopedic · 212d

Cleared Jun 04, 1992

MODIFICATION MODEL 7201 INSUFFLATOR

Northgate Technologies, Inc.

Obstetrics & Gynecology · 251d

Cleared Jun 04, 1992

MULTI USE LAPAROSCOPY ELECTROSURGICAL INSTRUMENT

General & Plastic Surgery · 199d

Cleared Jun 04, 1992

STEALTH DILATION CATHETER SYSTEM (MODIFIED)

Target Therapeutics

Cardiovascular · 323d

Cleared Jun 04, 1992

CEDIA FERRITIN ASSAY

Microgenics Corp.

Chemistry · 132d

Cleared Jun 04, 1992

HANDI-LASE CO2 SURGICAL LASER INSTRUMENT

Sorenson Laboratories, Inc.

General & Plastic Surgery · 114d

Cleared Jun 04, 1992

BLOOD ADMINISTRATION SET

Douglas Medical Products Corp.

General Hospital · 105d

Cleared Jun 04, 1992

DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA

Baxter Diagnostics, Inc.

Hematology · 99d

Cleared Jun 04, 1992

SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700

Obstetrics & Gynecology · 94d

Cleared Jun 04, 1992

General & Plastic Surgery · 92d

Cleared Jun 04, 1992

SYNELISA CARDIOLIPIN ANTIBODIES

Elias U.S.A., Inc.

Immunology · 80d

Cleared Jun 04, 1992

SURGICAL INSTRUMENT, DISPOSABLE

Macro Medical, Inc.

Orthopedic · 72d

Cleared Jun 04, 1992

CONTINU-FLO(R) SOLUTION SET

Baxter Healthcare Corp

General Hospital · 55d

Cleared Jun 04, 1992

KING DIAGNOSTICS ALT (GPT) REAGENT

King Diagnostics, Inc.

Chemistry · 30d

Cleared Jun 04, 1992

SPINAL POSITIONING FRAME

General & Plastic Surgery · 15d

Cleared Jun 03, 1992

CARDIAC CATHERIZATION KIT

Abbott Laboratories

Cardiovascular · 252d

Cleared Jun 03, 1992

IVAC PC ANIFUSER

General Hospital · 208d

Cleared Jun 03, 1992

ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM

Odontit Systeme

Cleared Jun 03, 1992

INTRODUCER CATHETER

Interventional Therapeutics Corp.

Cardiovascular · 176d

Cleared Jun 03, 1992

FAST-CATH HEMOSTASIS INTRODUCER

Cardiovascular · 104d

Cleared Jun 03, 1992

GORE TUNNELER, MODIFICATION

W.L. Gore & Associates, Inc.

Cardiovascular · 93d

Cleared Jun 03, 1992

IOLAB POWER I.V. POLE

Site Microsurgical Systems, Inc.

Ophthalmic · 85d

Cleared Jun 03, 1992

CERVICAL PASSIVE MOTION

Rehabilitative Resources, Inc.

Physical Medicine · 77d