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"
2497–2520 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 12, 2008
FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK
K080209 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 228d
Cleared Sep 10, 2008
DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR
K081789 · JIT
Siemens Healthcare Diagnostics, Inc.
Chemistry · 77d
Cleared Sep 08, 2008
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST...
K081013 · LRG
Siemens Healthcare Diagnostics
Microbiology · 152d
Cleared Aug 29, 2008
DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE,...
K081731 · CGS
Siemens Healthcare Diagnostics
Chemistry · 71d
Cleared Aug 28, 2008
STERILE, POWDER-FREE, LATEX EXAM GLOVES, MODELS 2D7018PF SERIES, 2D7028PF SERIES
K081464 · LYY
Cardinalhealth
General Hospital · 93d
Cleared Aug 26, 2008
TYSONBIO LINK HEALTH MANAGEMENT SYSTEM
K081726 · NBW
Tyson Bioresearch, Inc.
Chemistry · 69d
Cleared Aug 26, 2008
SKINSENSE POLYISOPRENE UNDERGLOVE
K081180 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 123d
Cleared Aug 25, 2008
CENTRICITY PACS IW
K082318 · LLZ
Ge Healthcare Dynamic Imaging Solutions
Radiology · 12d
Cleared Aug 22, 2008
DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440
K082030 · DLJ
Siemens Healthcare Diagnostics, Inc.
Toxicology · 36d
Cleared Aug 20, 2008
VIP PULMONARY FUNCTION SYSTEM
K080510 · BTY
Viasys Healthcare GmbH
Anesthesiology · 177d
Cleared Aug 15, 2008
MASS CASUALTY VENTILATOR, MODEL MCV100
K080063 · BTL
Allied Healthcare Products, Inc.
Anesthesiology · 218d
Cleared Aug 13, 2008
AVEA VENTILATOR
K081837 · CBK
Cardinal Health 207, Inc.
Anesthesiology · 44d
Cleared Aug 08, 2008
DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM...
K081299 · DDG
Siemens Healthcare Diagnostics, Inc.
Immunology · 92d
Cleared Aug 08, 2008
ACS 180 AND ADVIA CENTAUR FT4 IMMUNOASSAYS
K080167 · CEC
Siemens Healthcare Diagnostics
Chemistry · 198d
Cleared Aug 07, 2008
NAVIGATOR APPLICATIONS SUITE
K081941 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 30d
Cleared Aug 07, 2008
ALATECH POWDERED LATEX PATIENT EXAMINATION GLOVE
K080606 · LYY
Alatech Healthcare, LLC
General Hospital · 156d
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