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

Filters: Cleared only ×
175,230 results
40273–40296 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 05, 2013
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE...
K131666 · DWF
Maquet Cardiopulmonary, AG
Cardiovascular · 28d
Cleared Jul 05, 2013
MECTALIF
K131671 · MAX
Medacta International
Orthopedic · 28d
Cleared Jul 03, 2013
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE...
K120977 · GGN
International Technidyne Corp.
Hematology · 457d
Cleared Jul 03, 2013
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
K123074 · MHX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 275d
Cleared Jul 03, 2013
ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL,...
K123171 · CJY
HORIBA ABX SAS
Chemistry · 267d
Cleared Jul 03, 2013
STIMLASE 2000 LOW LEVEL LASER THERAPY SYSTEM
K123177 · ILY
Laserstim, Inc.
Physical Medicine · 267d
Cleared Jul 03, 2013
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
K123256 · DEM
The Binding Site Group , Ltd.
Immunology · 258d
Cleared Jul 03, 2013
CULTURE DISH 40 MM, CULTURE DISH 60 MM, MICRO DROPLET CULTURE DISH, 5 WELL...
K123641 · MQK
Hertart
Obstetrics & Gynecology · 219d
Cleared Jul 03, 2013
FASTPACK VITAMIN D
K123983 · MRG
Qualigen, Inc.
Chemistry · 189d
Cleared Jul 03, 2013
2008K@HOME HEMODIALYSIS MACHINE
K124035 · ONW
Fresenius Medical Care North America
Gastroenterology & Urology · 187d
Cleared Jul 03, 2013
DYNASTY ACETABULAR SYSTEM WITH CERAMIC
K130376 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 139d
Cleared Jul 03, 2013
NEWTOM VGI AND NEWTOM 5G
K130442 · OAS
Qr S.R.L.
Radiology · 132d
Cleared Jul 03, 2013
ABSOCLEAR
K130553 · FRO
Pharmaplast S.A.E.
General & Plastic Surgery · 121d
Cleared Jul 03, 2013
IFUSION
K130656 · HKI
Optovue, Inc.
Ophthalmic · 113d
Cleared Jul 03, 2013
MENICON UNIQUE PH MULTI-PURPOSE SOLUTION
K130805 · MRC
Menicon Co, Ltd.
Ophthalmic · 100d
Cleared Jul 03, 2013
CYBER TM FAMILY
K131081 · GEX
Quanta System Spa
General & Plastic Surgery · 76d
Cleared Jul 03, 2013
2MP COLOR LCD MONITOR, RADIFORCE MX215
K131090 · LLZ
Eizo Corporation
Radiology · 76d
Cleared Jul 03, 2013
DIGITAL RADIOGRAPHY CXDI-701C WIRELESS, DIGITAL RADIOGRAPHY CXDI-70IG...
K131106 · MQB
Canon, Inc.
Radiology · 75d
Cleared Jul 03, 2013
ARTHREX DISTAL RADIUS PLATE SYSTEM
K131474 · HRS
Arthrex, Inc.
Orthopedic · 42d
Cleared Jul 03, 2013
EMERGE MEDICAL LOCKING ONE-THIRD TUBULAR PLATE SYSTEM
K131480 · HRS
Emerge Medical
Orthopedic · 42d
Cleared Jul 03, 2013
CP150 ELECTROCARDIOGRAPH
K131573 · DPS
Welch Allyn, Inc.
Cardiovascular · 34d
Cleared Jul 03, 2013
EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID...
K131575 · PHX
Exactech, Inc.
Orthopedic · 33d
Cleared Jul 03, 2013
LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
K131670 · HRS
Biomet, Inc.
Orthopedic · 26d
Cleared Jul 03, 2013
AIRSTRIP REMOTE PATIENT MONITORING PHILIPS ADAPTER
K131786 · MWI
Airstrip Technologies, LP
Cardiovascular · 15d