FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
69529–69552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 2003
MODIFICATION TO AURORA DS
K033586 · GEX
Syneron Medical, Ltd.
General & Plastic Surgery · 27d
Cleared Dec 10, 2003
SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS)
K033669 · HRS
Smith & Nephew, Inc.
Orthopedic · 19d
Cleared Dec 09, 2003
REDLINE ANTHRAX ALERT TEST
K030370 · NPO
Tetracore, Inc.
Microbiology · 308d
Cleared Dec 09, 2003
CD LEYCOM PRESSURE/VOLUME CATHETERS
K031599 · DQO
Cd Leycom BV
Cardiovascular · 202d
Cleared Dec 09, 2003
SPIROTEL, MODEL 29-1020
K031643 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 196d
Cleared Dec 09, 2003
MONA LISA ASPIRATION NEEDLE
K032208 · MQE
Fertility Technology Resources, Inc.
Obstetrics & Gynecology · 144d
Cleared Dec 09, 2003
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K032690 · LFL
Misonix, Inc.
General & Plastic Surgery · 98d
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