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"
2905–2928 of 5,281
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared May 02, 2005
EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT)
K050495 · FMF
Baxter Healthcare Corp., Bioscience
General Hospital · 63d
Cleared Apr 27, 2005
SPINEMED S200B/S200C
K051013 · ITH
Cert Health Sciences, LLC
Physical Medicine · 6d
Cleared Apr 27, 2005
REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE
K050837 · FLL
Ge Healthcare
General Hospital · 26d
Cleared Apr 22, 2005
ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS
K043228 · NBC
Bayer Healthcare, LLC
Chemistry · 151d
Cleared Apr 22, 2005
STAT MEDICAL PEN NEEDLE
K042917 · FMI
Emergogroup, Inc.
General Hospital · 182d
Cleared Apr 21, 2005
LANDLEX, MODEL S300X
K050792 · INI
Cycling and Health Tech. Industry R&D...
Physical Medicine · 24d
Cleared Apr 21, 2005
MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K043531 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 121d
Cleared Apr 08, 2005
BLOOD GLUCOSE MONITORING SYSTEM
K043543 · NBW
American Healthcare, Inc.
Chemistry · 109d
Cleared Apr 08, 2005
EASYGLUCO IGM-0002 G2
K043512 · CGA
American Healthcare, Inc.
Chemistry · 109d
Cleared Apr 07, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS
K050714 · DXN
Health & Life Co., Ltd.
Cardiovascular · 20d
Cleared Apr 07, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT
K050711 · DXN
Health & Life Co., Ltd.
Cardiovascular · 20d
Cleared Apr 05, 2005
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM
K050587 · DXN
Health & Life Co., Ltd.
Cardiovascular · 28d
Cleared Apr 05, 2005
HEALTH BUDDY APPLIANCE
K050567 · DRG
Health Hero Network, Inc.
Cardiovascular · 32d
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