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
12697–12720 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 23, 2022
Safety Insulin Syringes
K220061 · MEG
Berpu Medical Technology Co., Ltd.
General Hospital · 225d
Cleared Aug 23, 2022
Picosecond Laser System (Model PS10-A and PS10-B)
K220268 · GEX
Beijing Adss Development Co., Ltd.
General & Plastic Surgery · 204d
Cleared Aug 23, 2022
ClearCheck Model RADCC V2
K220583 · IYE
Radformation, Inc.
Radiology · 175d
Cleared Aug 23, 2022
Disposable Medical Safety Hypodermic Needle
K220603 · FMI
Hantech Medical Device Co., Ltd.
General Hospital · 174d
Cleared Aug 23, 2022
Bifix Hybrid Abutment Cement
K220640 · EMA
Voco GmbH
Dental · 172d
Cleared Aug 23, 2022
OneTouch Delica Plus Lancing System
K221546 · QRL
Asahi Polyslider Co., Ltd.
General & Plastic Surgery · 88d
Cleared Aug 23, 2022
GMK 3D Metal Tibial Tray
K221850 · MBH
Medacta International S.A.
Orthopedic · 57d
Cleared Aug 23, 2022
1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
K222257 · MOS
Invivo Corporation (Business Trade...
Radiology · 27d
Cleared Aug 23, 2022
FONA XDC
K222274 · EHD
Fona S.R.L
Radiology · 25d
Cleared Aug 22, 2022
Powered Inflatable Tube Massager - SLIM UP DRAIN
K201730 · IRP
Foggiare Technologies, LLC
Physical Medicine · 789d
Cleared Aug 22, 2022
Powder Free Latex Examination Glove, Non-Sterile
K211601 · LYY
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 455d
Cleared Aug 22, 2022
SurGuard3 Safety Hypodermic Needle
K212095 · FMI
Terumo Europe N.V.
General Hospital · 412d
Cleared Aug 22, 2022
Auxilock Draw Tight Suture-Based Anchor
K213109 · MBI
Auxein Medical Private Limited
Orthopedic · 332d
Cleared Aug 22, 2022
VPS Rhythm DLX Device with TipTracker Technology
K220363 · LJS
Arrow International, LLC (A...
General Hospital · 195d
Cleared Aug 22, 2022
ClearCalc Model RADCA V2
K220582 · MUJ
Radformation, Inc.
Radiology · 174d
Cleared Aug 22, 2022
Arthrex FiberTape and TigerTape Cerclage Sutures
K221485 · HTN
Arthrex, Inc.
General & Plastic Surgery · 91d
Cleared Aug 22, 2022
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy...
K221528 · DXF
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Aug 22, 2022
HS40 Diagnostic Ultrasound System
K221599 · IYN
Samsung Medison Co., Ltd.
Radiology · 81d
Cleared Aug 22, 2022
SafetiHeel, MediHeel, Novaplus
K221604 · FMK
Nsp Tech Pte, Ltd.
General & Plastic Surgery · 81d
Cleared Aug 22, 2022
SABER .014 PTA Dilatation Catheter
K221832 · LIT
Cordis US Corp
Cardiovascular · 60d
Cleared Aug 22, 2022
CUSA Clarity Ultrasonic Surgical Aspirator System
K221835 · LFL
Integra LifeSciences Corporation
General & Plastic Surgery · 60d
Cleared Aug 19, 2022
CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW
K203078 · FXX
Huizhou Tianchang Industrial Co., Ltd.
General Hospital · 675d
Cleared Aug 19, 2022
Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices
K212525 · LHI
Advcare Medical
General Hospital · 373d
Cleared Aug 19, 2022
Bonvadis Topical Cream
K212554 · FRO
Stemcyte, Inc.
General & Plastic Surgery · 371d