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
37561–37584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 20, 2014
NAMSA CHEMICAL PROCESS
K132291 · JOJ
North American Science Assoc., Inc.
General Hospital · 301d
Cleared May 20, 2014
OSTEOSPAN MORPHEUS
K132377 · MQV
Biogennix, LLC
Orthopedic · 293d
Cleared May 20, 2014
OSTEOSYMBIONICS PATIENT-SPECIFIC CRANIAL PLATE
K133082 · GXN
Osteosymbionics, LLC
Neurology · 232d
Cleared May 20, 2014
PRIME ZOOM STRETCHER
K140095 · INK
Stryker Corporation
Physical Medicine · 126d
Cleared May 20, 2014
MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL...
K140165 · DWF
Medtronic, Inc.
Cardiovascular · 118d
Cleared May 20, 2014
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY
K140446 · MKZ
Becton, Dickinson & CO
Microbiology · 88d
Cleared May 20, 2014
BD VIPER LT SYSTEM
K140447 · OOI
Becton, Dickinson and Company
Microbiology · 88d
Cleared May 20, 2014
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448 · LSL
Becton, Dickinson & CO
Microbiology · 88d
Cleared May 20, 2014
ASAP OTC WOUND DRESSING GEL
K140483 · FRO
Abl Medical, LLC
General & Plastic Surgery · 83d
Cleared May 20, 2014
Y WIRE 2
K140576 · HXI
Safewire, LLC
Orthopedic · 75d
Cleared May 20, 2014
GENERAL AND PLASTIC SURGERY
K140835 · NEU
Scion Medical Technologies, LLC
General & Plastic Surgery · 48d
Cleared May 20, 2014
ACUMED SUTURE ANCHOR SYSTEM
K140925 · MBI
Acumed, LLC
Orthopedic · 39d
Cleared May 20, 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · MNH
Spineart
Orthopedic · 36d
Cleared May 20, 2014
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K141023 · HSB
Ellipse Technologies, Inc.
Orthopedic · 29d
Cleared May 19, 2014
VISION BIOSYSTEMS ESTROGEN RECEPTOR CLONE 6F11 (ER 6F11)
K122556 · MYA
Leica Biosystems Newcastle, Ltd.
Pathology · 635d
Cleared May 19, 2014
MAXIO
K132108 · JAK
Perfint Healthcare Pvt, Ltd.
Radiology · 315d
Cleared May 19, 2014
THUNDERBEAT
K132703 · GEI
Olympus Medical Systems Corp.
General & Plastic Surgery · 263d
Cleared May 19, 2014
DMS 300-2W HOLTER ECG RECORDER
K133014 · MWJ
Diagnostic Monitoring Software
Cardiovascular · 236d
Cleared May 19, 2014
PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE
K133793 · OMB
Persyst Development Corporation
Neurology · 157d
Cleared May 19, 2014
VIEWFLEX XTRA ICE CATHETER
K133853 · OBJ
Irvine Biomedical, Inc., A St. Jude...
Cardiovascular · 151d
Cleared May 19, 2014
NXSTAGE SYSTEM ONE
K140526 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 76d
Cleared May 19, 2014
INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450,...
K141015 · MHX
Philips Medizinsysteme Boeblingen...
Cardiovascular · 28d
Cleared May 19, 2014
CS2 MULTI-HOLE ACETABULAR SHELL
K141043 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 26d
Cleared May 16, 2014
AR1000 SERIES ULTRASONIC WOUND THERAPY SYSTEM
K131096 · NRB
Arobella Medical, LLC
General & Plastic Surgery · 393d