Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
46441–46464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 20, 2011
Spacer-G and Spacer-K
K101356 · KWL
Tecres S.P.A.
Orthopedic · 494d
Cleared Sep 20, 2011
TANDEMHEART PUMP
K110493 · KFM
Cardiacassist, Inc.
Cardiovascular · 210d
Cleared Sep 20, 2011
AMSCO CHIMERON SMALL STEAM STERILIZER
K111223 · FLE
STERIS Corporation
General Hospital · 141d
Cleared Sep 20, 2011
NEXWAVE COMBO MUSCLE STIMULATOR SYSTEM
K111279 · IPF
Zynex Medical, Inc.
Physical Medicine · 138d
Cleared Sep 20, 2011
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V,...
K111451 · HCG
MicroVention, Inc.
Neurology · 118d
Cleared Sep 20, 2011
NT 2000 LESIONING GENERATOR
K111576 · GXD
Neuro Therm, Inc.
Neurology · 106d
Cleared Sep 20, 2011
FULL AUTO TONOMETER MODEL TX-20
K111710 · HKX
Canon Inc. -Medical Equipment Group
Ophthalmic · 92d
Cleared Sep 20, 2011
SORIN CENTRIFUGAL PUMP 5 (CP5)
K112225 · DWA
Sorin Group Deutschland GmbH
Cardiovascular · 48d
Cleared Sep 20, 2011
CERALAS 147NM DIODE LASER SYSTEM
K112253 · GEX
Biolitec, Inc.
General & Plastic Surgery · 46d
Cleared Sep 20, 2011
BIOGEL PI ORTHOPRO BROWN SURGICAL GLOVE
K112257 · KGO
Molnlycke Health Care Us, LLC
General Hospital · 46d
Cleared Sep 19, 2011
EDLEN IMAGING - GEMINI DUSB
K103290 · MUH
Edlen Imaging, LLC
Radiology · 315d
Cleared Sep 19, 2011
NXSTAGE PUREFLOW SL
K111174 · FKR
Nxstage Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Sep 19, 2011
MOBILETT MIRA
K111912 · IZL
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Sep 19, 2011
WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TEST
K112236 · LAF
Guangzhou Wondfo Biotech Co., Ltd.
Chemistry · 46d
Cleared Sep 19, 2011
GLUCOSE METER-CHECK CONTROL SOLUTION FOR AGAMATRIX WAVESENSE
K112356 · JJX
Bionostics, Inc.
Chemistry · 34d
Cleared Sep 19, 2011
PROCEDURAL STRECHER WITH INTELLIDRIVE P8000
K112502 · INK
Hill-Rom Co.
Physical Medicine · 20d
Cleared Sep 16, 2011
DIACHECK BLOOD GLUCOSE MONITORING SYSTEM MODEL: PREMIUM
K100806 · NBW
Delbio Incorporation
Chemistry · 543d
Cleared Sep 16, 2011
PICASSO/ PICASSO LITE/ PICASSO PERIO
K102359 · GEX
Amd Lasers, LLC
General & Plastic Surgery · 393d
Cleared Sep 16, 2011
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
K102778 · JOY
CellaVision AB
Hematology · 357d
Cleared Sep 16, 2011
Z10 WHEELCHAIR PUSH AND BRAKE ASSIST DEVICE
K111278 · ITI
Otto Bock Healthcare LP
Physical Medicine · 134d
Cleared Sep 16, 2011
ECHOBRIGHT
K111355 · CAZ
Life-Tech, Inc.
Anesthesiology · 123d
Cleared Sep 16, 2011
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL...
K111490 · KRA
Ev3, Inc.
Cardiovascular · 108d
Cleared Sep 16, 2011
SURGICAL MASKS
K111559 · FXX
Shanghai Neo-Medical Import & Export...
General Hospital · 102d
Cleared Sep 16, 2011
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET...
K111629 · PHX
Encore Medical, L.P.
Orthopedic · 95d