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

143089–143112 of 175,230

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

Cleared Jul 18, 1986

SONOLAYER-L, SAL-38A, WITH SCANNER SAL-38AS

Toshiba Medical Systems

Radiology · 156d

Cleared Jul 18, 1986

MICRON, MICROVASCULAR DOPPLER

Diagnostic Electronics Corp.

Cardiovascular · 147d

Cleared Jul 18, 1986

MODEL 545-45 LASER FOR EAR, NOSE & THROAT

Britt Corp., Inc.

Ear, Nose, Throat · 126d

Cleared Jul 18, 1986

ENTUBE TM, ENTERAL FEEDING TUBE

Gastroenterology & Urology · 93d

Cleared Jul 18, 1986

MODEL 450 INFRARED IMAGING SYSTEM

Radiology · 85d

Cleared Jul 18, 1986

MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM

Hewlett-Packard Co.

Obstetrics & Gynecology · 85d

Cleared Jul 18, 1986

IMPLANTABLE ELECTRODE LEAD, MODEL 030-436

Telectronics, Inc.

Cardiovascular · 72d

Cleared Jul 18, 1986

COBE ACCESSORY INTERFACE MODULE (AIM)

Cobe Laboratories, Inc.

Cardiovascular · 65d

Cleared Jul 18, 1986

ACUSON L382 AND L312 TRANSDUCERS

Acuson Computed Sonography

Cardiovascular · 66d

Cleared Jul 18, 1986

MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM

Medicor USA , Ltd.

Radiology · 56d

Cleared Jul 18, 1986

ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT

Beckman Instruments, Inc.

Immunology · 51d

Cleared Jul 18, 1986

CARDIOMET 4000 GAS MONITORING SYSTEMS

Biomedical Sensors, Inc.

Cardiovascular · 49d

Cleared Jul 18, 1986

CAMINO HAND DRILL - MODEL 030

Camino Laboratories, Inc.

Neurology · 42d

Cleared Jul 18, 1986

PHONIC EAR, MODEL PE 1800

Phonic Ear, Inc.

Ear, Nose, Throat · 42d

Cleared Jul 18, 1986

General Hospital · 32d

Cleared Jul 18, 1986

ICS APOLIPOPROTEIN B REAGENT TEST KIT

Beckman Instruments, Inc.

Immunology · 24d

Cleared Jul 18, 1986

LS3000 CANNULA UTERINE SUCTION

Engineering, Inc.

Obstetrics & Gynecology · 18d

Cleared Jul 18, 1986

AUSTENAL ACUPAC HI DENTURE BASE MATERIAL

Austenal Dental, Inc.

Cleared Jul 18, 1986

W. C. Green, D.D.S.

Physical Medicine · 10d

Cleared Jul 18, 1986

V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT

Scientific Pharmaceuticals, Inc.

Cleared Jul 18, 1986

MODIFIED PENOX LIFT CHAIR

Penox Technologies, Inc.

Physical Medicine · 7d

Cleared Jul 17, 1986

HDC CHEMO-PORT (VASCULAR)

General Hospital · 343d

Cleared Jul 17, 1986

Angiomed U.S., Inc.

Cardiovascular · 220d

Cleared Jul 17, 1986

ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR

General Hospital · 206d