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"
2329–2352 of 5,198
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Dec 04, 2009
DIDGET BLOOD GLUCOSE METER, MODEL 6181
K090628 · NBW
Bayer Healthcare, LLC
Chemistry · 270d
Cleared Dec 03, 2009
SILS PORT MODEL SILSPT15
K093372 · GCJ
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 35d
Cleared Nov 30, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093277 · LYZ
Tangshan Green Healthcare Co., Ltd.
General Hospital · 42d
Cleared Nov 30, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093272 · LYZ
Tangshan Huamei Healthcare Co., Ltd.
General Hospital · 42d
Cleared Nov 27, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962,...
K093387 · DXN
Andon Health Co, Ltd.
Cardiovascular · 28d
Cleared Nov 25, 2009
3.0T 16 CHANNEL HEAD NECK SPINE COIL
K093348 · MOS
Ge Healthcare Coils (Usa Instruments,...
Radiology · 29d
Cleared Nov 20, 2009
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL
K092993 · JJX
Siemens Healthcare Diagnostics
Chemistry · 53d
Cleared Nov 18, 2009
STERILE WATER FOR INHALATION FLEX BAG, USP
K090915 · BTT
Cardinal Health, Inc.
Anesthesiology · 231d
Cleared Nov 17, 2009
CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK
K093389 · DXN
Computerized Screening, Inc.
Cardiovascular · 18d
Cleared Nov 17, 2009
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
K092271 · IYN
Ge Healthcare
Radiology · 112d
Cleared Nov 16, 2009
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB
K092163 · DXN
Health & Life Co., Ltd.
Cardiovascular · 123d
Cleared Nov 12, 2009
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
K093410 · GDW
Surgical Devices, A Divsion of Tyco...
General & Plastic Surgery · 10d
Cleared Nov 12, 2009
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K093408 · GAM
Surgical Devices, A Division of Tyco...
General & Plastic Surgery · 10d
Cleared Nov 10, 2009
BESMED JET NEBULIZER BOTTLE SET
K091272 · CAF
Besmed Health Business Corp
Anesthesiology · 194d
Cleared Nov 06, 2009
DX-D IMAGING PACKAGE
K092669 · MQB
Agfa Healthcare N.V.
Radiology · 67d
Cleared Nov 06, 2009
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION
K091914 · JJX
Bionostics, Inc.
Chemistry · 129d
Cleared Oct 30, 2009
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
K093300 · KGO
Cardinal Health, Inc.
General Hospital · 9d
Cleared Oct 30, 2009
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · LHI
Baxter Healthcare Corporation
General Hospital · 87d
Cleared Oct 30, 2009
SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX...
K083133 · FRO
Andover Healthcare, Inc.
General & Plastic Surgery · 372d
Cleared Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
K091916 · DAP
Siemens Healthcare Diagnostics
Hematology · 121d
Cleared Oct 23, 2009
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025
K092919 · LON
Siemens Healthcare Diagnostics
Microbiology · 30d
Cleared Oct 21, 2009
REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
K092425 · OWQ
Ascent Healthcare Solutions
Cardiovascular · 75d
Cleared Oct 21, 2009
DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE,...
K092283 · DFZ
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Oct 09, 2009
AUTO DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, MODEL KP-7770
K092806 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 28d