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

137113–137136 of 175,230

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

Cleared Jan 05, 1988

BIOTROL BICARBONATE (CO2) UV HP)

Biotrol, USA, Inc.

Chemistry · 34d

Cleared Jan 04, 1988

ULTRASOUND BREAST SCANNER W/CHANGES IN TRANS/RECE.

Labsonics, Inc.

Obstetrics & Gynecology · 207d

Cleared Jan 04, 1988

MODIFIED OMNISTIM(TM) ELECTRICAL MUSCLE STIMULATOR

Physio Technology, Inc.

Physical Medicine · 90d

Cleared Jan 04, 1988

ENDOSCOPES FOR SINUS SURGERY

Richards Medical Co., Inc.

Ear, Nose, Throat · 80d

Cleared Jan 04, 1988

VARIOUS CARDIAC CRYOPROBES HAVING DIA. & COS. DIFF

Spembly Medical , Ltd.

Ophthalmic · 73d

Cleared Jan 04, 1988

NEEDLE CONTAINER

American Medical Technology, Inc.

General Hospital · 68d

Cleared Jan 04, 1988

MODIFIED SIMPSON PERIPHERAL ATHEROCATH

Devices For Vascular Intervention, Inc.

Cardiovascular · 61d

Cleared Jan 04, 1988

KODAK REMOTE ALARM UNIT

Eastman Kodak Company

Radiology · 33d

Cleared Jan 04, 1988

Neurology · 33d

Cleared Dec 31, 1987

SOKEN(TM) ELECTRONIC MUSCLE STIMULATOR

Rehab Medical Specialties, Inc.

Physical Medicine · 143d

Cleared Dec 31, 1987

FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM

Orthopedic Systems, Inc.

Orthopedic · 114d

Cleared Dec 31, 1987

KIRSCHNER UNICONDYLAR KNEE SYSTEM

Kirschner Medical Corp.

Orthopedic · 93d

Cleared Dec 31, 1987

ENTERON LIVER BIOPSY TRAY

Gastroenterology & Urology · 87d

Cleared Dec 31, 1987

Pie Data Medical BV

Ear, Nose, Throat · 85d

Cleared Dec 31, 1987

AML CALCAR FEMORAL PROSTHESIS

Orthopedic · 84d

Cleared Dec 31, 1987

Anesthesiology · 43d

Cleared Dec 30, 1987

EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX

Radiology · 300d

Cleared Dec 30, 1987

FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA

Obstetrics & Gynecology · 196d

Cleared Dec 30, 1987

BCM DRY PACK BICARBONATE MIXER

Specialty Dialysis Services

Gastroenterology & Urology · 141d

Cleared Dec 30, 1987

GASTROINTESTINAL FLEXIBLE BIOSPY FORCEPS

Medical Engineering Laboratory, Inc.

Gastroenterology & Urology · 138d

Cleared Dec 30, 1987

MSI 9000 SERIES BED

Med Service, Inc.

General Hospital · 135d

Cleared Dec 30, 1987

Marquette Medical, Inc.

General Hospital · 121d

Cleared Dec 30, 1987

PUMP TUBING SET

Marquette Medical, Inc.

General Hospital · 121d

Cleared Dec 30, 1987

Anesthesiology · 118d