FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

5,281 results for "health"
3505–3528 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 31, 1998
MP-3 POWER BASE CHAIR
K982066 · ITI
Merits Health Products., Inc.
Physical Medicine · 81d
Cleared Aug 24, 1998
CONVERTORS, SPUNBONDED, FLASHSPUN POLYOLEFIN GOWNS
K982369 · FYC
Allegiance Healthcare Corp.
General Hospital · 48d
Cleared Aug 17, 1998
SOLUTION ADMINISTRATION SET
K981792 · FPA
Baxter Healthcare Corp
General Hospital · 88d
Cleared Aug 11, 1998
SCC-23 SAFETY CLAMP AND CUTTER
K982464 · KNA
Women First Healthcare, Inc.
Obstetrics & Gynecology · 27d
Cleared Aug 11, 1998
PRISMA CFM (CONTINUOUS FLUID MANAGEMENT SYSTEM)
K981681 · KDI
Gambro Healthcare
Gastroenterology & Urology · 90d
Cleared Aug 04, 1998
NASAL INTERFACE MODEL 7910
K974453 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 252d
Cleared Jul 26, 1998
3M RED DOT RESTING EKG ELECTRODE, CATALOG 2360
K974445 · DRX
3M Healthcare
Cardiovascular · 243d
Cleared Jul 24, 1998
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K981774 · LYY
Pwa Industries Sdn. Bhd.
General Hospital · 65d
Cleared Jul 23, 1998
CLEAR HUB SPINAL NEEDLE 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA...
K982269 · MIA
Allegiance Healthcare Corp.
Anesthesiology · 24d
Cleared Jul 10, 1998
CONVERTORS TRILAMINATE DRAPES
K981818 · KKX
Allegiance Healthcare Corp.
General Hospital · 49d
Cleared Jul 10, 1998
BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER
K974652 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 210d
Cleared Jul 07, 1998
PERCUTANEOUS BREAST BIOPSY (PBB)
K972328 · KNW
Urothealth System, Inc.
Gastroenterology & Urology · 379d
Cleared Jul 02, 1998
BABY PACIFIER DIGITAL THERMOMETER
K981456 · FLL
K-Jump Health Co., Ltd.
General Hospital · 70d
Cleared Jun 29, 1998
MODEL 7410 VOYAGER
K974879 · BZD
Healthdyne Technologies, Inc.
Anesthesiology · 181d
Cleared Jun 25, 1998
POLYSORB SUTURE
K981935 · GAM
United States Surgical, A Division of...
General & Plastic Surgery · 23d
Cleared Jun 22, 1998
HEALTH + AID PREMIUM PRE-POWDERED LATEX EXAMINATION GLOVES
K981893 · LYY
M.R.G. Industries Sdn. Bhd.
General Hospital · 24d
Cleared Jun 18, 1998
STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT
K981167 · CAF
Dhd Healthcare Corp.
Anesthesiology · 78d
Cleared Jun 12, 1998
COSGROVE CLAMP
K974769 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 172d
Cleared May 29, 1998
GEEN MEDISOX
K981296 · DWL
Geen Healthcare, Inc.
General Hospital · 50d
Cleared May 21, 1998
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
K974571 · FPA
Baxter Healthcare Corp
General Hospital · 164d
Cleared May 20, 1998
TITANIUM SPINAL ROD SYSTEM
K980862 · MNH
United States Surgical, A Division of...
Orthopedic · 76d
Cleared May 19, 1998
PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234
K980658 · FJI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared May 19, 1998
PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236
K980656 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 89d
Cleared May 18, 1998
GAMBRO HEMODIALYSIS WATER TREATMENT SYSTEM
K981085 · FIP
Gambro Healthcare
Gastroenterology & Urology · 54d