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
113425–113448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 19, 1993
ELISA-DOXA JO-1
K924950 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA COMBI-4
K924951 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
ELISA-DOXA COMBI-6
K924952 · LLL
Advanced Biological Products, Inc.
Immunology · 231d
Cleared May 19, 1993
MRINNERVU ENDORECTAL PROSTATE COIL
K925029 · LNH
Medrad, Inc.
Radiology · 226d
Cleared May 19, 1993
TRACE MODEL #'S 840, 841, 842, 845
K925145 · FYH
Trace Medical Equipment, Inc.
General Hospital · 218d
Cleared May 19, 1993
SPACER
K925870 · MJG
Bip USA, Inc.
General & Plastic Surgery · 181d
Cleared May 19, 1993
INSTRUMENTARIUM MEGA4 HT
K925987 · LNH
Instrumentarium Imaging, Inc.
Radiology · 175d
Cleared May 19, 1993
SUTUREMATE
K926126 · MDM
Surgical Safety Products, Inc.
General & Plastic Surgery · 166d
Cleared May 19, 1993
SAT PAD(TM)
K926416 · LNH
Alliance Pharmaceutical Corp.
Radiology · 147d
Cleared May 19, 1993
STERNAL BAND
K930015 · JDQ
Stony Brook Surgical Innovations, Inc.
Orthopedic · 135d
Cleared May 19, 1993
RSX 30HF
K930792 · IZO
Fischer Imaging Corp.
Radiology · 92d
Cleared May 19, 1993
ADVANTX SYSTEM
K931049 · IZO
GE Medical Systems
Radiology · 79d
Cleared May 19, 1993
ITE MODEL ADOBE 100 FULL CUSTOM
K931590 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 49d
Cleared May 19, 1993
ITC MODEL ADOBE 100 CANAL
K931591 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 49d
Cleared May 19, 1993
MAG CONNECTORS AND AIRWAY EXTENSIONS
K931800 · BZA
Mag, Inc.
Anesthesiology · 37d
Cleared May 19, 1993
BREATHING FILTER
K931842 · CAH
Mag, Inc.
General Hospital · 36d
Cleared May 18, 1993
LUQUE V SPINAL SYSTEM
K921256 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 428d
Cleared May 18, 1993
LV-20 VOLUMETER, 20 MHZ DOPPLER BLOOD FLOW METER
K922034 · DPW
Titronics Medical Instruments, Inc.
Radiology · 382d
Cleared May 18, 1993
ISOLA(R) TANDEM CONNECTOR
K922504 · KWP
Acromed Corp.
Orthopedic · 356d
Cleared May 18, 1993
AUGMENT POSTERIOR SPINAL FIXATION SYSTEM
K922672 · KWP
Sofamor Danek Mfg., Inc.
Orthopedic · 348d
Cleared May 18, 1993
SALMAN SINUS BUTTON
K922902 · KAM
Boston Medical Products, Inc.
General & Plastic Surgery · 336d
Cleared May 18, 1993
VENTILATION TUBES W/ HYDROGEL COATING
K923353 · ETD
Microbio-Medics, Inc.
Ear, Nose, Throat · 314d
Cleared May 18, 1993
INTEGRITY 2
K923970 · GZJ
Medrotech Corp.
Neurology · 285d
Cleared May 18, 1993
PWB LUMBAR LAMINAR HOOKS WITH SET SCREWS
K924381 · KWP
Cross Medical Products, Inc.
Orthopedic · 260d