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"
2473–2496 of 5,280
Search insights Median review: 94d Cleared: 99% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 29, 2009
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION...
K090594 · CFN
Siemens Healthcare Diagnostics
Immunology · 55d
Cleared Apr 27, 2009
DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454
K090236 · LOJ
Siemens Healthcare Diagnostics
Immunology · 84d
Cleared Apr 27, 2009
DS N95 SURGICAL MASKS AND FLAT SURGICAL
K090131 · MSH
Shanghai Dasheng Health Products
General Hospital · 96d
Cleared Apr 22, 2009
MODIFICATION TO V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K091087 · GAM
Surgical Devices, Tyco Healthcare...
General & Plastic Surgery · 7d
Cleared Apr 22, 2009
HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
K090074 · JOW
Hygia Health Services, Inc.
Cardiovascular · 100d
Cleared Apr 15, 2009
RTX 3371
K090886 · DRG
Tunstall Healthcare
Cardiovascular · 15d
Cleared Apr 10, 2009
WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SP
K082065 · GXY
Well-Life Healthcare Limited
Neurology · 262d
Cleared Apr 06, 2009
CARESTREAM DRX-1 SYSTEM
K090318 · MQB
Carestream Health, Inc.
Radiology · 56d
Cleared Apr 02, 2009
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL),...
K083386 · CJY
Siemens Healthcare Diagnostics
Chemistry · 136d
Cleared Apr 01, 2009
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K090323 · NLH
Ascent Healthcare Solutions
Cardiovascular · 51d
Cleared Apr 01, 2009
NAVIGATOR APPLICATIONS SUITE
K083098 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 166d
Cleared Mar 30, 2009
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT,...
K083487 · NRP
Siemens Healthcare Diagnostics
Toxicology · 125d
Cleared Mar 26, 2009
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K082662 · GAM
Surgical Devices, Tyco Healthcare...
General & Plastic Surgery · 195d
Cleared Mar 24, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083853 · DHB
Siemens Healthcare Diagnostics
Immunology · 90d
Cleared Mar 24, 2009
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN...
K083445 · CFN
Siemens Healthcare Diagnostics
Immunology · 123d
Cleared Mar 18, 2009
SPETZLER SCALP RETRACTOR CLAMPS (VARIOUS STYLES AND SIZES)
K090272 · GZT
Cardinal Health, Inc.
Neurology · 42d
Cleared Mar 16, 2009
ZEST NASAL MASK
K083832 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 83d
Cleared Mar 13, 2009
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR,...
K083463 · JZG
Siemens Healthcare Diagnostics
Immunology · 109d
Cleared Mar 13, 2009
SYMCARE DIABETES MANAGEMENT PROGRAM
K083263 · NBW
Symcare Personalized Health...
Chemistry · 128d
Cleared Mar 11, 2009
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR,...
K083906 · NDY
Siemens Healthcare Diagnostics
Chemistry · 71d
Cleared Mar 11, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083314 · DHB
Siemens Healthcare Diagnostics
Immunology · 121d
Cleared Mar 09, 2009
DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS)
K083339 · CIC
Siemens Healthcare Diagnostics, Inc.
Chemistry · 117d
Cleared Mar 04, 2009
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · CBK
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 133d
Cleared Feb 27, 2009
DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA...
K083465 · CGS
Siemens Healthcare Diagnostics
Chemistry · 95d