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

5,280 results for "health"
2569–2592 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Aug 06, 2008
TRICOS A RESORBABLE SUBSTITUTE
K081721 · LYC
Baxter Healthcare Corp
Dental · 49d
Cleared Aug 05, 2008
DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108
K081992 · MKW
Siemens Healthcare Diagnostics, Inc.
Toxicology · 22d
Cleared Aug 04, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56
K081319 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 84d
Cleared Aug 04, 2008
V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK...
K081289 · FPA
Baxter Healthcare Corp
General Hospital · 89d
Cleared Aug 04, 2008
SELF-ADHESIVE ELECTRODES
K080276 · GXY
Cathay Health Care Equipment...
Neurology · 182d
Cleared Jul 31, 2008
MASIMO COMPATIBLE SATURATION MODULE, E-MASIMO
K081870 · DQA
GE Healthcare Finland Oy
Anesthesiology · 30d
Cleared Jul 31, 2008
KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080326 · DXN
Andon Health Co, Ltd.
Cardiovascular · 176d
Cleared Jul 30, 2008
CARESTREAM DR LONG LENGTH IMAGING SYSTEM FOR DR 7500 SYSTEM
K081836 · KPR
Carestream Health, Inc.
Radiology · 30d
Cleared Jul 29, 2008
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP),...
K081294 · NQD
Siemens Healthcare Diagnostics, Inc.
Chemistry · 83d
Cleared Jul 29, 2008
REPROCESSED MASIMO PULSE OXIMETER SENSORS
K081238 · NLF
Ascent Healthcare Solutions
Anesthesiology · 89d
Cleared Jul 28, 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
K081976 · LLZ
Agfa Healthcare Corporation
Radiology · 17d
Cleared Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K081963 · MQB
Agfa Healthcare Corporation
Radiology · 15d
Cleared Jul 25, 2008
HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510
K080969 · CAF
Medi Nuclear Corp., Inc.
Anesthesiology · 112d
Cleared Jul 21, 2008
AG-605 BLOOD GLUCOSE MONITORING SYSTEM
K073030 · NBW
Andon Health Co, Ltd.
Chemistry · 269d
Cleared Jul 17, 2008
ADVIA CENTAUR HAVM ASSAY
K081716 · LOL
Siemens Healthcare Diagnostics, Inc.
Microbiology · 29d
Cleared Jul 09, 2008
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K081329 · NLH
Ascent Healthcare Solutions
Cardiovascular · 58d
Cleared Jul 07, 2008
LOCI CARDIAC TROPONIN I CALIBRATOR, MODEL RC621
K081683 · JIT
Siemens Healthcare Diagnostics
Chemistry · 20d
Cleared Jul 03, 2008
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS,...
K081643 · MMI
Siemens Healthcare Diagnostics
Chemistry · 21d
Cleared Jul 02, 2008
DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
K081300 · JHM
Siemens Healthcare Diagnostics
Chemistry · 55d
Cleared Jul 02, 2008
KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K080319 · DXN
Andon Health Co, Ltd.
Cardiovascular · 147d
Cleared Jun 27, 2008
INTEL HEALTH GUIDE, MODEL: PHS6000
K080798 · DRG
Intel Corp.
Cardiovascular · 99d
Cleared Jun 26, 2008
FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
K080734 · BTY
Viasys Healthcare GmbH
Anesthesiology · 104d
Cleared Jun 20, 2008
PRO TENS, MODEL WL-240 RX
K080304 · GZJ
Well-Life Healthcare Limited
Neurology · 136d
Cleared Jun 19, 2008
MICRO-TOUCH NITRAFREE
K080536 · LZA
Ansell Healthcare Products, LLC
General Hospital · 113d