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"
1657–1680 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 13, 2015
HOME ACCESS AIC TEST
K141944 · LCP
Home Access Health Corp.
Chemistry · 239d
Cleared Mar 11, 2015
DRX-EVOLUTION
K141837 · KPR
Carestream Health, Inc.
Radiology · 247d
Cleared Mar 09, 2015
KIMGUARD ONE-STEP Sterilization Wrap
K142782 · FRG
Kimberly-Clark Health Care
General Hospital · 164d
Cleared Mar 06, 2015
3.0T GEM RT Open Array
K143389 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 100d
Cleared Mar 05, 2015
MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb...
K143646 · BTT
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 73d
Cleared Mar 05, 2015
TraumaCad Mobile Release 1.0
K142923 · LLZ
Voyant Health, Ltd.
Radiology · 148d
Cleared Mar 04, 2015
Insta-Gard Surgical and Procedure Face Mask
K142990 · FXX
Cardinal Health200, LLC
General Hospital · 139d
Cleared Mar 04, 2015
SVED Wound Treatment System
K142916 · OMP
Cardinalhealth
General & Plastic Surgery · 148d
Cleared Feb 26, 2015
IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000...
K143373 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 93d
Cleared Feb 25, 2015
IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE...
K143636 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 65d
Cleared Feb 17, 2015
Master Caution Device MCD
K142476 · DXH
Healthwatch , Ltd.
Cardiovascular · 167d
Cleared Feb 10, 2015
Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems
K142472 · IYN
Ge Healthcare
Radiology · 160d
Cleared Feb 05, 2015
CO2 monitoring line with and without in-line filter
K143150 · CCK
Besmed Health Business Corp
Anesthesiology · 94d
Cleared Feb 04, 2015
SIGNA Creator, SIGNA Explorer
K143251 · LNH
Ge Healthcare (Ge Medical Systems, LLC)
Radiology · 84d
Cleared Jan 29, 2015
LOGIQ P9, LOGIQ P7
K143452 · IYN
Ge Healthcare
Radiology · 58d
Cleared Jan 29, 2015
LISTERINE Sensitivity Defense Mouthrinse
K143155 · LBH
Johnson & Johnson Healthcare...
Dental · 87d
Cleared Jan 27, 2015
ADVIA Centaur IgE Master Curve Material
K143680 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 34d
Cleared Jan 23, 2015
IMMULITE 2000 CEA Calibration Verification Material
K143639 · JJX
Siemens Healthcare Diagnostics
Immunology · 32d
Cleared Jan 23, 2015
WOUND DRESSING WITH MANUKA HONEY
K133729 · FRO
Manuka Health New Zealand , Ltd.
General & Plastic Surgery · 413d
Cleared Jan 18, 2015
DECISIO HEALTH PATIENT DASHBOARD
K142106 · MWI
Decisio Health, Inc.
Cardiovascular · 170d
Cleared Jan 14, 2015
IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000...
K143504 · JJX
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared Jan 07, 2015
Unity Network ID
K142840 · MWI
Ge Healthcare
Cardiovascular · 99d
Cleared Jan 06, 2015
IMPAX Agility
K142316 · LLZ
Agfa Healthcare N.V.
Radiology · 140d
Cleared Dec 24, 2014
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000...
K143352 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d