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"
3817–3840 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 16, 1994
NEEDLELESS URINE SAMPLING PORT
K944236 · KNX
Kendall Healthcare Products Co....
Gastroenterology & Urology · 76d
Cleared Nov 16, 1994
AIRWATCH MONITOR
K941226 · BZH
Enact Health Management Systems
Anesthesiology · 247d
Cleared Nov 10, 1994
COMPLETE CPR KIT
K941008 · CBP
Mtm Health Products , Ltd.
Anesthesiology · 254d
Cleared Nov 10, 1994
CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM
K935979 · BZD
Devilbiss Health Care, Inc.
Anesthesiology · 332d
Cleared Nov 07, 1994
CELEBRITY XL SC445
K944939 · INI
Pride Health Care, Inc.
Physical Medicine · 31d
Cleared Nov 07, 1994
CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · KKX
Baxter Healthcare Corp
General Hospital · 609d
Cleared Nov 03, 1994
INTERMATE XLV ELASTOMERIC INFUSION SYSTEM
K943664 · MEB
Baxter Healthcare Corp
General Hospital · 98d
Cleared Nov 01, 1994
4-O2 JR. (CPR MOUTH BARRIER)
K945177 · CBP
Eagle Health Supplies
Anesthesiology · 8d
Cleared Oct 07, 1994
EXAMINATION GLOVES
K942877 · LYY
Masif Healthcare Products Sdn. Bhd.
General Hospital · 112d
Cleared Oct 07, 1994
3M FLUID IRRIGATION SYSTEM
K941388 · HRX
3M Healthcare
Orthopedic · 199d
Cleared Oct 07, 1994
GUARDIAN SURGEON'S GOWNS
K931562 · FYA
Atkins Healthcare Services
General Hospital · 556d
Cleared Oct 03, 1994
CURADERM ALGINATE HYDROCOLLOID
K943636 · KMF
Kendall Healthcare Products Co....
General & Plastic Surgery · 68d
Cleared Sep 30, 1994
BAXTER CT DIALYZER
K926568 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 638d
Cleared Sep 21, 1994
KENDALL MODU-VAC CLOSED SUCTION SYSTEM
K944251 · BSY
Kendall Healthcare Products Co....
Anesthesiology · 21d
Cleared Sep 20, 1994
AUTO SUTURE* ANTI-FOG DEVICE**
K944249 · FEB
United States Surgical, A Division of...
General Hospital · 21d
Cleared Sep 06, 1994
AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH
K934704 · GCJ
United States Surgical, A Division of...
General & Plastic Surgery · 341d
Cleared Aug 24, 1994
SURGICAL STAPLE
K942606 · GDW
United States Surgical, A Division of...
General & Plastic Surgery · 84d
Cleared Aug 24, 1994
SARNS TURBO MEMBRANE OXYGENATOR MODIFICATION
K941653 · DTZ
3M Health Care, Sarns
Cardiovascular · 141d
Cleared Aug 22, 1994
AUTO SUTURE MODIFIED GRIP
K942885 · FBQ
United States Surgical, A Division of...
General & Plastic Surgery · 66d
Cleared Aug 17, 1994
BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS
K943605 · FMI
Baxter Healthcare Corp
General Hospital · 23d
Cleared Aug 17, 1994
BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS
K943594 · FMI
Baxter Healthcare Corp
General Hospital · 23d
Cleared Aug 16, 1994
UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
K941225 · DTZ
Baxter Healthcare Corp
Cardiovascular · 155d
Cleared Aug 11, 1994
OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360
K941950 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 112d
Cleared Aug 11, 1994
SILK*SKIN SCAR TREATMENT
K941197 · MDA
Puritas Health Care, Inc.
General & Plastic Surgery · 150d