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
26281–26304 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 04, 2018
leva Pelvic Floor Trainer
K180637 · HIR
Renovia, Inc.
Gastroenterology & Urology · 23d
Cleared Apr 03, 2018
Kisses Plus Implant System
K172630 · DZE
Achimhai Medical Corporation
Dental · 214d
Cleared Apr 03, 2018
High-Flo Silver Polyethylene Catheter
K172635 · DQO
Cook Incorporated
Cardiovascular · 214d
Cleared Apr 03, 2018
DSM Biomedical Calcium Phosphate Cement
K173362 · MQV
Kensey Nash Corporation Dba Dsm...
Orthopedic · 159d
Cleared Apr 03, 2018
LigaPASS
K173506 · OWI
Medicrea International SA
Orthopedic · 141d
Cleared Apr 03, 2018
Genesys Spine Binary Lumbar Plate System
K173885 · KWQ
Genesys Spine
Orthopedic · 103d
Cleared Apr 03, 2018
OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua...
K173958 · LPL
Visco Vision, Inc.
Ophthalmic · 96d
Cleared Apr 03, 2018
Infinity-Lock Button System
K180243 · HTN
Xiros, Ltd.
Orthopedic · 64d
Cleared Apr 03, 2018
dpl IIa Panel
K180320 · OHS
Led Technologies, Inc.
General & Plastic Surgery · 57d
Cleared Apr 03, 2018
PRECICE STRYDE System
K180503 · HSB
Nuvasive Specialized Orthopedics, Inc.
Orthopedic · 36d
Cleared Apr 03, 2018
Unite Connect for Clinical Systems
K180566 · MSX
Ascom (Sweden) AB
Cardiovascular · 29d
Cleared Apr 03, 2018
AcuPulse (previously called AcuPulse 30/40 ST)
K180597 · GEX
Lumenis, Ltd.
General & Plastic Surgery · 28d
Cleared Apr 03, 2018
Surefire Spark Infusion System
K180677 · DQO
Surefire Medical, Inc.
Cardiovascular · 19d
Cleared Apr 02, 2018
Instrument basket, for EndoEYE
K171692 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 299d
Cleared Apr 02, 2018
GC Fuji Direct
K172382 · EMA
GC America, Inc.
Dental · 237d
Cleared Apr 02, 2018
Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
K173639 · OWB
Siemens Medi Cal Solutions, Inc.
Radiology · 129d
Cleared Apr 02, 2018
K-D Balance
K173669 · LXV
King-Devick Technologies, Inc.
Ear, Nose, Throat · 123d
Cleared Apr 02, 2018
Microcyn Antimicrobial Hydrogel
K173896 · FRO
Sonoma Pharmaceuticals, Inc.
General & Plastic Surgery · 101d
Cleared Apr 02, 2018
CREO® Stabilization System
K180210 · NKB
Globus Medical, Inc.
Orthopedic · 68d
Cleared Apr 02, 2018
Varian Head Frame
K180586 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Mar 30, 2018
UF(II) Implant System
K170608 · DZE
Dio Corporation
Dental · 394d
Cleared Mar 30, 2018
AMSure® Enteral Feeding Syringe with ENFit Tip
K171857 · PNR
Amsino International, Inc.
Gastroenterology & Urology · 282d
Cleared Mar 30, 2018
Dr’s Finder NEO
K171867 · LQY
Good Doctors Co., Ltd.
Dental · 281d
Cleared Mar 30, 2018
Dimesol Tubing Sets for Hemodialysis
K171952 · FJK
Dimesol, Inc.
Gastroenterology & Urology · 274d