FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

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

5,198 results for "health"

3433–3456 of 5,198

Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital

Cleared Jul 07, 1998

PERCUTANEOUS BREAST BIOPSY (PBB)

Urothealth System, Inc.

Gastroenterology & Urology · 379d

Cleared Jul 02, 1998

BABY PACIFIER DIGITAL THERMOMETER

K-Jump Health Co., Ltd.

General Hospital · 70d

Cleared Jun 29, 1998

MODEL 7410 VOYAGER

Healthdyne Technologies, Inc.

Anesthesiology · 181d

Cleared Jun 25, 1998

POLYSORB SUTURE

United States Surgical, A Division of...

General & Plastic Surgery · 23d

Cleared Jun 22, 1998

HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES

M.R.G. Industries Sdn. Bhd.

General Hospital · 24d

Cleared Jun 18, 1998

STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT

Dhd Healthcare Corp.

Anesthesiology · 78d

Cleared Jun 12, 1998

Allegiance Healthcare Corp.

Cardiovascular · 172d

Cleared May 29, 1998

Geen Healthcare, Inc.

General Hospital · 50d

Cleared May 21, 1998

SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE

Baxter Healthcare Corp

General Hospital · 164d

Cleared May 20, 1998

TITANIUM SPINAL ROD SYSTEM

United States Surgical, A Division of...

Orthopedic · 76d

Cleared May 19, 1998

PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234

Baxter Healthcare Corp

Gastroenterology & Urology · 89d

Cleared May 19, 1998

PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236

Baxter Healthcare Corp

Gastroenterology & Urology · 89d

Cleared May 18, 1998

GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM

Gambro Healthcare

Gastroenterology & Urology · 54d

Cleared May 15, 1998

3M CDI QUICK-CELLS WITH HEPARIN TREATMENT

Cardiovascular · 79d

Cleared May 11, 1998

United States Surgical, A Division of...

General & Plastic Surgery · 42d

Cleared Apr 25, 1998

AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER

United States Surgical, A Division of...

General & Plastic Surgery · 261d

Cleared Apr 22, 1998

DUAL LUER LOCK CAP

Baxter Healthcare Corp

General Hospital · 12d

Cleared Apr 21, 1998

FERNO HEALTHCARE RECLINE-A-BATH 2

Ferno-Washington, Inc.

Physical Medicine · 106d

Cleared Apr 09, 1998

MODIFICATION TO REFLEX AEC LINEAR STAPLER/CUTTER

Urohealth Systems, Inc.

General & Plastic Surgery · 76d

Cleared Apr 01, 1998

HTL MALE CONDOM

Reddy Medtech Health Products , Ltd.

Obstetrics & Gynecology · 89d

Cleared Mar 27, 1998

United States Surgical, A Division of...

General & Plastic Surgery · 72d

Cleared Mar 19, 1998

STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR

Dhd Diemolding Healthcare Div.

Anesthesiology · 182d

Cleared Mar 13, 1998

LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING

Evergrade Healthcare Products Sdn Bhd

General Hospital · 169d

Cleared Mar 11, 1998

CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210)

Baxter Healthcare Corp

Gastroenterology & Urology · 383d