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
114529–114552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1993
HI-TORQUE SPORT-T(TM) GUIDE WIRE
K915554 · DQX
Peripheral Systems Group
Cardiovascular · 426d
Cleared Feb 09, 1993
INDXTM DIP-S-TICKSTM
K920569 · LSQ
Intercare Diagnostics, Inc.
Microbiology · 368d
Cleared Feb 09, 1993
PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP
K922733 · JDI
Orthomet, Inc.
Orthopedic · 246d
Cleared Feb 09, 1993
ARTHREX PLUS
K923142 · HRX
Arthrex, Inc.
Orthopedic · 225d
Cleared Feb 09, 1993
FOUNDATION KNEE SYSTEM
K923277 · JWH
Encore Orthopedics, Inc.
Orthopedic · 218d
Cleared Feb 09, 1993
NUCLEOTOME 3.5 MM AUTOMATED PERCUTANEOUS LUMBAR
K923525 · HRX
Surgical Dynamics, Inc.
Orthopedic · 208d
Cleared Feb 09, 1993
ETEX HIP REPLACEMENT SYSTEM
K925895 · JDI
Etex Co.
Orthopedic · 85d
Cleared Feb 09, 1993
BABYSET AND PAC (PULMONARY ASSIST CIRCUIT)
K930252 · CAI
Bird Life Design
Anesthesiology · 32d
Cleared Feb 08, 1993
RESORABPLUG
K920118 · LZN
Sofamor Danek Mfg., Inc.
Orthopedic · 392d
Cleared Feb 08, 1993
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
K921800 · FBK
Mill-Rose Laboratory
Gastroenterology & Urology · 300d
Cleared Feb 08, 1993
POWDER FREE NITRILE GLOVE
K922116 · KGO
Hpi, Inc.
General Hospital · 333d
Cleared Feb 08, 1993
ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES
K922890 · HRX
Arthrex, Inc.
Orthopedic · 238d
Cleared Feb 08, 1993
ACESSORY PACK
K923638 · LIT
Medtronics Interventional Vascular
Cardiovascular · 202d
Cleared Feb 08, 1993
DISPOSABLE OPTICAL VALVULOTOME
K924075 · MGZ
Endovascular, Inc.
Cardiovascular · 180d
Cleared Feb 08, 1993
VACUPLUS(R) STAR-SEP(TM)
K924363 · JKA
Starplex Scientific, Inc.
Chemistry · 164d
Cleared Feb 08, 1993
OLYMPUS ALBUMIN REAGENT
K924368 · CIX
Olympus Corp.
Chemistry · 164d
Cleared Feb 08, 1993
ARTHREX ATRAUMATIC MINI-GRASPER
K925455 · HRX
Arthrex, Inc.
Orthopedic · 115d
Cleared Feb 08, 1993
VISTA 4000 SIGMA
K925600 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 95d
Cleared Feb 08, 1993
OLYMPUS CHOLESTEROL REAGENT
K925603 · CHH
Olympus Corp.
Chemistry · 95d
Cleared Feb 08, 1993
MICROVASIVE INSURG FLAT WIRE BASKETS
K925879 · LQR
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared Feb 08, 1993
ACCESS TOTAL BHCG ASSAY
K926198 · JHI
Bio-Rad Laboratories, Inc.
Chemistry · 61d
Cleared Feb 05, 1993
SYSTEM ATHENA, MODIFICATION
K911611 · DRT
S & W Medico Teknik
Cardiovascular · 668d
Cleared Feb 05, 1993
DAVOL LAPAROSCOPIC DISSECTORS
K920234 · HET
C.R. Bard, Inc.
Obstetrics & Gynecology · 385d
Cleared Feb 05, 1993
LASERSTAR IMAGER
K921215 · LMC
Frantz Imaging, Inc.
Radiology · 329d