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"
2857–2880 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 05, 2005
HL 200 ELECTRONIC STETHOSCOPE
K050169 · DQD
Health & Life Co., Ltd.
Cardiovascular · 69d
Cleared Apr 05, 2005
OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M
K042506 · DXN
Omron Healthcare, Inc.
Cardiovascular · 202d
Cleared Apr 05, 2005
OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N
K042505 · DXN
Omron Healthcare, Inc.
Cardiovascular · 202d
Cleared Apr 01, 2005
BLOOD HAND PUMP ADMINISTRATION SET
K050115 · BRZ
Cardinal Health, Alaris Products
General Hospital · 73d
Cleared Mar 31, 2005
H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF &...
K050491 · DXN
Health & Life Co., Ltd.
Cardiovascular · 34d
Cleared Mar 31, 2005
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
K043418 · FED
Cook Urological, Inc.
Gastroenterology & Urology · 108d
Cleared Mar 30, 2005
HL168JP
K050249 · DXN
Health & Life Co., Ltd.
Cardiovascular · 55d
Cleared Mar 25, 2005
SE INFUSION SYSTEM WITH MMS
K043590 · FRN
Cardinal Health, Alaris Products
General Hospital · 87d
Cleared Mar 15, 2005
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
K050112 · KPL
Prime Pacific Health Innovations...
Gastroenterology & Urology · 56d
Cleared Mar 01, 2005
TRIFIT 700
K033646 · DRT
Healthfirst Corp.
Cardiovascular · 467d
Cleared Feb 25, 2005
ENDOASSIST
K043284 · GCJ
Armstrong Healthcare Limited
General & Plastic Surgery · 91d
Cleared Feb 18, 2005
SECURELOC
K050023 · DYB
Specialized Health Products, Inc.
Cardiovascular · 44d
Cleared Feb 16, 2005
TURBO TEMP TRIO
K050230 · FLL
Cardinal Health, Alaris Products
General Hospital · 15d
Cleared Feb 09, 2005
HL 188 & HL 189 BODY FAT METER
K043414 · MNW
Health & Life Co., Ltd.
Gastroenterology & Urology · 58d
Cleared Feb 08, 2005
ADVIA IMS CARBAMAZEPINE METHOD
K042808 · KLT
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Feb 08, 2005
ADVIA IMS VALPROIC ACID METHOD
K042807 · LEG
Bayer Healthcare, LLC
Chemistry · 119d
Cleared Feb 03, 2005
HOME HEALTH POWER WHEELCHAIR, MODEL HC-200
K042719 · ITI
Home Health Technology Co., Ltd.
Physical Medicine · 126d
Cleared Jan 26, 2005
BEWELL, MODEL SC 20
K043326 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 55d
Cleared Jan 19, 2005
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES...
K043508 · KGO
Ansell Healthcare Products, LLC
General Hospital · 30d
Cleared Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 75d
Cleared Jan 18, 2005
DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER
K042709 · EZL
Tyco Healthcare
Gastroenterology & Urology · 110d
Cleared Jan 12, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET
K043437 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Jan 12, 2005
GE SIGNA EXCITE MR SURGICAL OPTION
K043262 · LNH
Ge Healthcare
Radiology · 49d
Cleared Jan 12, 2005
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · BZE
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 380d