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"
2545–2568 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Oct 08, 2008
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE
K082486 · NBW
Bayer Healthcare, LLC
Chemistry · 41d
Cleared Oct 07, 2008
JUMAO MANUAL WHEELCHAIR
K082784 · IOR
Danyang Jumao Healthcare Equipment...
Physical Medicine · 14d
Cleared Oct 06, 2008
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
K082217 · LGZ
Arizant Healthcare, Inc.
General Hospital · 61d
Cleared Oct 01, 2008
SMARTSIGNS MINPULSE
K081572 · DQA
Huntleigh Healthcare , Ltd.
Anesthesiology · 119d
Cleared Sep 22, 2008
DIMENSION EXL N-TERNMIAL PRO-BRAIN NATRIURETIC PEPTIDE (NTP) FLEX REAGENT...
K082645 · NBC
Siemens Healthcare Diagnostics
Chemistry · 11d
Cleared Sep 17, 2008
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
K081738 · CAF
Health & Life Co., Ltd.
Anesthesiology · 90d
Cleared Sep 16, 2008
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K082023 · NLH
Ascent Healthcare Solutions
Cardiovascular · 62d
Cleared Sep 12, 2008
SLEEPSTYLE 200 AUTO SERIES HC254
K081029 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 154d
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