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"
1897–1920 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 04, 2013
IMMULITE 2000 ANTI-CCP IGG ASSAY
K121576 · NHX
Siemens Healthcare Diagnostics, Inc.
Immunology · 309d
Cleared Mar 22, 2013
DIMENSION EXL WITH LM SYSTEM
K130276 · JJE
Siemens Healthcare Diagnostics, Inc.
Chemistry · 45d
Cleared Mar 21, 2013
CAPNO MODULE, 92517
K130112 · CCK
Spacelabs Healthcare
Anesthesiology · 64d
Cleared Mar 21, 2013
BP652N (HEM-6300-Z)
K123498 · DXN
Omron Healthcare, Inc.
Cardiovascular · 128d
Cleared Mar 21, 2013
APPS-HEALTH01
K122098 · DXN
Andon Health Co, Ltd.
Cardiovascular · 248d
Cleared Mar 21, 2013
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
K121981 · CEW
Siemens Healthcare Diagnostics
Chemistry · 258d
Cleared Mar 20, 2013
TX1 TISSUE REMOVAL SYSTEM
K123640 · LFL
Tenex Health
General & Plastic Surgery · 114d
Cleared Mar 15, 2013
ULTRASONIC NEBULIZER (MESH TYPE)
K121520 · CAF
K-Jump Health Co., Ltd.
Anesthesiology · 297d
Cleared Mar 14, 2013
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
K123933 · LTT
Siemens Healthcare Diagnostics, Inc.
Microbiology · 84d
Cleared Mar 14, 2013
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
K122534 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 206d
Cleared Mar 13, 2013
OPTIMA MR450W
K123522 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 118d
Cleared Mar 11, 2013
DX-D IMAGING PACKAGE
K122736 · MQB
Agfa Healthcare N.V.
Radiology · 173d
Cleared Mar 11, 2013
DISCOVERY TMAX MANUAL WHEELCHAIR
K113164 · IOR
Otto Bock Healthcare LP
Physical Medicine · 502d
Cleared Mar 08, 2013
UNI-PICC
K130034 · LJS
Health Line International Corporation
General Hospital · 60d
Cleared Mar 07, 2013
DIMENSION VISTA
K123677 · JIF
Siemens Healthcare Diagnostics
Chemistry · 97d
Cleared Mar 07, 2013
GENESIS HEALTH RECORD SYSTEM, (GHRS)
K123136 · NBW
Genesis Health Technologies
Chemistry · 153d
Cleared Mar 07, 2013
LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT
K122476 · NUC
Ansell Healthcare Products, LLC
Obstetrics & Gynecology · 205d
Cleared Mar 01, 2013
LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH...
K130245 · FMG
Baxter Healthcare Corp
General Hospital · 29d
Cleared Mar 01, 2013
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
K122955 · ELM
Wright Health Group , Ltd.
Dental · 157d
Cleared Feb 28, 2013
LOFRIC SENSE
K123751 · EZD
Wellspect Healthcare
Gastroenterology & Urology · 84d
Cleared Feb 28, 2013
DURABLUE STERILIZATION WRAP
K123289 · FRG
Cardinal Health-Medical Products and...
General Hospital · 129d
Cleared Feb 28, 2013
CARESCAPE RESPIRATORY MODULES, E-SCO, E-SCOV, E-SCAIOV AND ACCESSORIES
K123195 · CCL
GE Healthcare Finland Oy
Anesthesiology · 140d
Cleared Feb 22, 2013
1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL
K123681 · MOS
Wipro GE Healthcare Private, Ltd.
Radiology · 84d
Cleared Feb 22, 2013
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE
K122727 · LZA
Northstar Healthcare Holdings
General Hospital · 170d