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

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175,820 results
29905–29928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 2017
ClariFix Device
K162608 · GEH
Arrinex, Inc.
General & Plastic Surgery · 148d
Cleared Feb 14, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162668 · DXN
Andon Health Co, Ltd.
Cardiovascular · 141d
Cleared Feb 14, 2017
SIS Software
K162830 · LLZ
Surgical Information Sciences, Inc.
Radiology · 130d
Cleared Feb 14, 2017
FA100 SCCD (Sequential Continuous Contraction Device)
K162987 · IPF
Flowaid Medical Technologies, Corp
Physical Medicine · 110d
Cleared Feb 14, 2017
Simplexa C. difficile Direct
K163085 · OZN
Focus Diagnostics, Inc.:Dba Diasorin...
Microbiology · 103d
Cleared Feb 14, 2017
syngo Application Software
K163285 · LLZ
Siemens Medical Solution USA, Inc.
Radiology · 84d
Cleared Feb 14, 2017
Reveal LINQ Insertable Cardiac Monitor
K163460 · MXD
Medtronic, Inc.
Cardiovascular · 67d
Cleared Feb 14, 2017
ENSEAL X1 Large Jaw Tissue Sealer
K163548 · GEI
Ethicon Endo-Surgery, LLC
General & Plastic Surgery · 60d
Cleared Feb 14, 2017
SIGNA PET/MR
K163619 · OUO
Ge Medical Systems, LLC
Radiology · 54d
Cleared Feb 14, 2017
Erisma® LP Spinal Fixation System
K170163 · NKB
Clariance, Sas
Orthopedic · 27d
Cleared Feb 13, 2017
Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model...
K160610 · JAQ
Kobold, LLC
Radiology · 347d
Cleared Feb 13, 2017
JUVORA Dental Disc, Ceramill PEEK by JUVORA
K160918 · EBI
Juvora
Dental · 315d
Cleared Feb 13, 2017
VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)
K161510 · LON
bioMerieux, Inc.
Microbiology · 257d
Cleared Feb 13, 2017
Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx...
K162456 · OCC
Cepheid
Microbiology · 164d
Cleared Feb 13, 2017
KerraCel Ag Gelling Fiber Silver Dressing
K162508 · FRO
Exciton Technologies, Inc.
General & Plastic Surgery · 158d
Cleared Feb 13, 2017
MCS Bone Graft
K162860 · MQV
Bioventus, LLC
Orthopedic · 124d
Cleared Feb 13, 2017
POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs
K163146 · LZC
Hebei Hongsen Plastics Technology Co,...
General Hospital · 96d
Cleared Feb 13, 2017
Serranator Alto PTA Serration Balloon Catheter
K163380 · PNO
Cagent Vascular, LLC
Cardiovascular · 74d
Cleared Feb 13, 2017
Ultima HA Coated Half Pins and Wire
K163487 · JDW
Vilex IN Tennessee, Inc.
Orthopedic · 63d
Cleared Feb 13, 2017
Advance 14LP Low Profile PTA Balloon Dilatation Catheter
K170193 · LIT
Cook Incorporated
Cardiovascular · 21d
Cleared Feb 10, 2017
XSmart iQ
K161213 · EBW
Dentsply Sirona
Dental · 287d
Cleared Feb 10, 2017
Revision Femoral Stem
K161226 · LZO
Lima Corporate S.P.A.
Orthopedic · 284d
Cleared Feb 10, 2017
SteriTite Containers System & MediTray Products
K161415 · FRG
Case Medical, Inc.
General Hospital · 263d
Cleared Feb 10, 2017
Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH
K161606 · FMF
Terumo Europe N.V.
General Hospital · 245d