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"
3265–3288 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 30, 2001
MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH...
K012489 · DYB
Appriva Medical, Inc.
Cardiovascular · 27d
Cleared Aug 28, 2001
MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS
K011844 · CAW
Merits Health Products., Inc.
Anesthesiology · 77d
Cleared Aug 22, 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Aug 15, 2001
SPIRAL RADIUS 90-D SST SYSTEM
K012273 · MNH
United States Surgical, A Division of...
Orthopedic · 27d
Cleared Aug 14, 2001
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · KGO
Allegiance Healthcare Corp.
General Hospital · 71d
Cleared Aug 10, 2001
MP3U, POWER WHEELCHAIR
K011513 · ITI
Merits Health Products., Inc.
Physical Medicine · 86d
Cleared Aug 09, 2001
MUSCLE STIMULATOR SA-100
K010807 · IPF
Health@Fitness Technologies, Inc.
Physical Medicine · 146d
Cleared Aug 06, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K011751 · INI
Merits Health Products., Inc.
Physical Medicine · 61d
Cleared Aug 03, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 4
K011753 · INI
Merits Health Products., Inc.
Physical Medicine · 58d
Cleared Aug 03, 2001
MP-3C POWER BASE CHAIR, MODEL MP3C
K011687 · ITI
Merits Health Products., Inc.
Physical Medicine · 64d
Cleared Jul 30, 2001
RADS
K011054 · DIO
Chason Healthcare, LLC
Toxicology · 115d
Cleared Jul 20, 2001
LIVESURE BARBITURATES SCREEN TEST
K012133 · DIS
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Jul 20, 2001
LIVESURE BENZODIAZEPINES SCREEN TESTS
K012131 · JXM
Pan Probe Biotech, Inc.
Toxicology · 11d
Cleared Jul 20, 2001
LIVESURE PHENECYCLINE (PCP) SCREEN TESTS
K012107 · LCM
Pan Probe Biotech, Inc.
Toxicology · 15d
Cleared Jul 18, 2001
SURGICAL DYNAMICS MESH CAGE SYSTEM
K003709 · MQP
United States Surgical, A Division of...
Orthopedic · 229d
Cleared Jul 13, 2001
MALLEABLE SHAFT CLAMP
K011078 · DXC
Allegiance Healthcare Corp.
Cardiovascular · 95d
Cleared Jul 10, 2001
CYMUN-NBR POWDER FREE BLUE NITRILE EXAMINATION GLOVE
K011497 · LZA
Tillotson Healthcare Corp.
General Hospital · 56d
Cleared Jun 29, 2001
HOME HEALTH MONITORING SYSTEM
K010029 · DXN
Avid Care Corp.
Cardiovascular · 177d
Cleared Jun 28, 2001
MULTIRATE INFUSOR SV
K011317 · MEB
Baxter Healthcare Corp
General Hospital · 59d
Cleared Jun 25, 2001
ORACLE ORAL MASK
K003894 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 189d
Cleared Jun 22, 2001
POWDER FREE NITRILE EXAMINATION GLOVES
K010233 · LZA
P.T. Healthcare Glovindo
General Hospital · 149d
Cleared Jun 21, 2001
MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR...
K011593 · LZA
Ansell Healthcare Products, Inc.
General Hospital · 28d
Cleared Jun 21, 2001
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
K011389 · JCM
Canterbury Health Laboratories
Hematology · 45d
Cleared Jun 13, 2001
YOUNG-HEALTH SUPER EAR THERMOMETER
K002727 · FLL
Young Health Ind. Co., Ltd.
General Hospital · 286d