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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
69169–69192 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 2004
CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH...
K040636 · FPA
Smiths Medical MD, Inc.
General Hospital · 70d
Cleared May 19, 2004
LIQUICHEK TORCH PLUS IGM CONTROL
K040822 · JJY
Bio-Rad Laboratories, Inc.
Microbiology · 50d
Cleared May 19, 2004
SR ADORO
K040951 · EBG
Ivoclar Vivadent, Inc.
Dental · 37d
Cleared May 19, 2004
TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR
K041006 · MSD
Kendall
Gastroenterology & Urology · 30d
Cleared May 18, 2004
GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION...
K031357 · MJN
Possis Medical, Inc.
Cardiovascular · 384d
Cleared May 18, 2004
MEDSAFE CLICKSAFE SAFETY ANTISTICK SYRINGE WITH HYPODERMIC NEEDLE
K032517 · MEG
Medsafe Technologies, LLC
General Hospital · 278d
Cleared May 18, 2004
ANGIOJET XPEEDIOR 120 CATHETER AND ANGIOJET POWER PULSE SPRAY ANCILLARY KIT
K040013 · QEZ
Possis Medical, Inc.
Cardiovascular · 134d
Cleared May 18, 2004
MONODERM
K040477 · GAM
Surgical Specialties Corp
General & Plastic Surgery · 84d
Cleared May 18, 2004
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K040736 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 57d
Cleared May 18, 2004
S-SCORT...JR QUICKDRAW, MODEL 2400
K041154 · BTA
Sscor
General & Plastic Surgery · 15d
Cleared May 17, 2004
MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062
K033566 · DKZ
Rapid Diagnostics, Inc.
Toxicology · 187d
Cleared May 17, 2004
RAMP TROPONIN I ASSAY
K033745 · MMI
Response Biomedical Corp.
Chemistry · 168d
Cleared May 17, 2004
RAMP CK-MB ASSAY
K033747 · JHX
Response Biomedical Corp.
Chemistry · 168d
Cleared May 17, 2004
CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)
K033869 · FRO
Coloplast Corp.
General & Plastic Surgery · 157d
Cleared May 17, 2004
NEXT GENERATION SALEM SUMP
K040388 · FEG
Kendall
Gastroenterology & Urology · 90d
Cleared May 17, 2004
COONRAD/MORREY ELBOW CEMENT RESTRICTOR
K040389 · JDC
Zimmer, Inc.
Orthopedic · 90d
Cleared May 17, 2004
STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM
K040390 · HIH
Stryker Endoscopy
Obstetrics & Gynecology · 90d
Cleared May 17, 2004
AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST
K040464 · LDJ
Amedica Biotech, Inc.
Toxicology · 84d
Cleared May 17, 2004
AMS PERIGEE SYSTEM
K040623 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 69d
Cleared May 17, 2004
VUE 100 ULTRASOUND IMAGING SYSTEM
K040652 · IYO
Mobilsonic, Inc.
Radiology · 67d
Cleared May 17, 2004
ELECSYS TROPONIN T STAT TEST
K040733 · MMI
Roche Diagnostics Corp.
Chemistry · 56d
Cleared May 17, 2004
RESTORE WOUND CLEANSER
K040779 · KMF
Hollister, Inc.
General & Plastic Surgery · 52d
Cleared May 17, 2004
MULTICORE HB
K040795 · EBF
Ivoclar Vivadent, Inc.
Dental · 49d
Cleared May 17, 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
K040825 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 48d