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

Filters: Cleared only ×
176,076 results
70657–70680 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 09, 2003
OB1 OBSTETRICAL DOPPLER
K033156 · KNG
D. E. Hokanson, Inc.
Radiology · 70d
Cleared Dec 09, 2003
LATERAL ANGIOGRAPHIC C-ARM SUPPORT MH-400
K033184 · IZI
Shimadzu Corp.
Radiology · 69d
Cleared Dec 09, 2003
ALLURA XPER FD20
K033737 · OWB
Philips Medical Systems North...
Radiology · 11d
Cleared Dec 08, 2003
AUTOGEL PAD
K031018 · MUI
Rich-Mar Corp.
Radiology · 252d
Cleared Dec 08, 2003
FLUID FILLED TEETHERS
K031094 · KKO
Royal King Infant Products Co. , Ltd.
Dental · 245d
Cleared Dec 08, 2003
ENDOSKELETON TA VERTEBRAL BODY REPLACEMENT
K032812 · MQP
Orthovita, Inc.
Orthopedic · 90d
Cleared Dec 08, 2003
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
K032827 · KSR
Tyco Healthcare
Hematology · 89d
Cleared Dec 08, 2003
ACRA-CUT XPRESS 120
K032970 · HBF
Acra Cut, Inc.
Neurology · 76d
Cleared Dec 08, 2003
POTENS +
K033137 · JPA
Wada, Inc.
Hematology · 69d
Cleared Dec 08, 2003
GYNECARE TVT OBTURATOR SYSTEM
K033568 · OTN
Ethicon, Inc.
Gastroenterology & Urology · 26d
Cleared Dec 08, 2003
MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER
K033613 · DTA
Biotronik, Inc.
Cardiovascular · 21d
Cleared Dec 05, 2003
MIDA ALGORITHM REV. B
K023414 · DYC
Ortivus AB
Cardiovascular · 420d
Cleared Dec 05, 2003
VPT METER
K030829 · LLN
Xilas Medical, Inc.
Neurology · 266d
Cleared Dec 05, 2003
SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES
K031649 · CBF
Fink Engineering Pty, Ltd.
Anesthesiology · 191d
Cleared Dec 05, 2003
IMMUNOCARDSTAT HPSA
K032222 · LYR
Meridian Bioscience, Inc.
Microbiology · 137d
Cleared Dec 05, 2003
DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B),...
K032810 · KRH
Medtronic Heart Valves
Cardiovascular · 87d
Cleared Dec 05, 2003
HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
K032821 · NPP
Hygia Health Services, Inc.
Cardiovascular · 91d
Cleared Dec 05, 2003
CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET
K033519 · HRS
Biomet, Inc.
Orthopedic · 28d
Cleared Dec 05, 2003
BLUEPHASE
K033520 · EBZ
Ivoclar Vivadent, Inc.
Dental · 28d
Cleared Dec 05, 2003
EASY PASS HYDROPHILIC COATED VASCULAR GUIDEWIRE
K033542 · DQX
Galt Medical Corp.
Cardiovascular · 25d
Cleared Dec 05, 2003
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · LBS
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Dec 04, 2003
CLC2000 CATHETER PATENCY DEVICE
K021692 · FPA
Icu Medical, Inc.
General Hospital · 561d
Cleared Dec 04, 2003
LIFESITE HEMODIALYSIS ACCESS SYSTEM, CANNULA EXCHANGE KIT, INSERTION KIT,...
K023023 · MSD
Vasca, Inc.
Gastroenterology & Urology · 449d
Cleared Dec 04, 2003
RANDOX RX DAYTONA
K024014 · CGA
Randox Laboratories, Ltd.
Chemistry · 365d