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
107737–107760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1994
FEATHER-TOUCH SINGLE-STICK DEVICE
K942620 · FMK
Ulster Scientific, Inc.
General & Plastic Surgery · 20d
Cleared Jun 21, 1994
CHAKOFF ENDOSCOPY LAPAROSCOPIC INSTRUMENTATION
K932632 · GEI
Stephen Chakoff, Inc.
General & Plastic Surgery · 385d
Cleared Jun 21, 1994
OPTILASE MODEL 1000-100 ND: YAG LASER SYSTEM
K932883 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 372d
Cleared Jun 21, 1994
ASSURE SELF SEALING STERILIZATION POUCH
K933729 · KCT
Sultan Chemists, Inc.
General Hospital · 323d
Cleared Jun 21, 1994
SEARCH-SONIC
K934205 · IYO
Altana, Inc.
Radiology · 295d
Cleared Jun 21, 1994
AXSYM(TM) T-UPTAKE
K934312 · KHQ
Abbott Laboratories
Chemistry · 293d
Cleared Jun 21, 1994
AXSYM(TM) TOTAL T4
K934384 · CDX
Abbott Laboratories
Chemistry · 293d
Cleared Jun 21, 1994
AXSYM ULTRASENSITIVE HTSH
K934410 · JLW
Abbott Laboratories
Chemistry · 284d
Cleared Jun 21, 1994
CATCH AND HOLD OPTION FOR INSTASCAN
K934514 · LNH
Advanced Nmr Systems, Inc.
Radiology · 279d
Cleared Jun 21, 1994
AXSYM TOTAL T3
K934517 · CDP
Abbott Laboratories
Toxicology · 274d
Cleared Jun 21, 1994
AXSYM FREE THYROXINE ( FREE T4 )
K934544 · CEC
Abbott Laboratories
Chemistry · 272d
Cleared Jun 21, 1994
GDLH VARIABLE ANGLE CONNECTOR
K934582 · KWP
Danek Group, Inc.
Orthopedic · 271d
Cleared Jun 21, 1994
FLOVAL
K934835 · FJL
Olympus Corp.
Gastroenterology & Urology · 256d
Cleared Jun 21, 1994
SAPHIRE PLUS SURGICAL MIRROR
K934911 · EQH
San Diego Swiss Machining, Inc.
Ear, Nose, Throat · 250d
Cleared Jun 21, 1994
AXSYM THEOPHYLLINE
K935373 · KLS
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM CARBAMAZEPHINE
K935374 · KLT
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM PHENYTOIN ASSAY
K935375 · LGR
Abbott Laboratories
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM GENTAMICIN
K935376 · LCD
Abbott Mfg., Inc.
Toxicology · 225d
Cleared Jun 21, 1994
AXSYM LUTEINIZING HORMONE (LH)
K935611 · JJX
Abbott Laboratories
Chemistry · 211d
Cleared Jun 21, 1994
AXSYM FOLLICLE STIMULATING HORMONE (FSH)
K935612 · CGJ
Abbott Laboratories
Chemistry · 211d
Cleared Jun 21, 1994
AXSYM TOTAL B-HCG
K935673 · JHI
Abbott Laboratories
Chemistry · 207d
Cleared Jun 21, 1994
AXSYM PROLACTIN
K935675 · CFT
Abbott Laboratories
Chemistry · 207d
Cleared Jun 21, 1994
AIRHYTHM HEALTHCARE BED
K935837 · FNL
Healthcare Designs
General Hospital · 196d
Cleared Jun 21, 1994
AXSYM FERRITIN
K935847 · DBF
Abbott Laboratories
Immunology · 195d