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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121105–121128 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 21, 1991
ISOLA(TM) SPINE SYSTEM--EYE ROD
K911394 · KWP
Acromed Corp.
Orthopedic · 84d
Cleared Jun 21, 1991
MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)
K911495 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Jun 21, 1991
SYRINGE TIP CAP
K911638 · JKA
Concord/Portex
Chemistry · 71d
Cleared Jun 21, 1991
ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT.
K911990 · DRX
Somnitec, Inc.
Cardiovascular · 46d
Cleared Jun 20, 1991
MODIFIED MODELS 2000W AND 2000W OPTION H APNEA MON
K905575 · BZQ
Edentec Corp.
Anesthesiology · 190d
Cleared Jun 20, 1991
MEGA LUMBAR PUNCTURE KIT
K910089 · FMJ
Megadyne Medical Products, Inc.
General Hospital · 162d
Cleared Jun 20, 1991
MICROSTIM 100 MODEL 2C
K910580 · GZJ
Microstim, Inc.
Neurology · 129d
Cleared Jun 20, 1991
MEDISYSTEMS HEMODIALYSIS FISTULA SET
K910734 · FIE
Medisystems Corp.
Gastroenterology & Urology · 119d
Cleared Jun 20, 1991
THOROCENTESIS KIT
K910963 · JOL
Megadyne Medical Products, Inc.
General Hospital · 106d
Cleared Jun 20, 1991
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER
K911262 · GEA
Ethicon, Inc.
General & Plastic Surgery · 90d
Cleared Jun 20, 1991
UNIPOLAR COAGULATOR PROBE SYSTEM
K911274 · GEI
American Surgical Instruments Corp.
General & Plastic Surgery · 90d
Cleared Jun 20, 1991
OBTRASOUND STETHOSCOPE FETAL CALC
K911453 · KNG
Medasonics, Inc.
Radiology · 78d
Cleared Jun 20, 1991
FLEXIBLE CHOLEDOCHOSCOPE
K911480 · FBN
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 20, 1991
MEADOX(R) SURGIMED(R) BIOPSY GUN II
K911635 · KNW
Meadox Surgimed, Inc.
Gastroenterology & Urology · 70d
Cleared Jun 20, 1991
IMMULITE(TM) HCG
K911796 · DHA
Cirrus Diagnostics, Inc.
Chemistry · 59d
Cleared Jun 20, 1991
RX-5000 MRI SYSTEM
K911892 · LNH
Resonex, Inc.
Radiology · 55d
Cleared Jun 20, 1991
TELEX MODEL TLP, IN-THE-EAR
K912204 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Jun 20, 1991
STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY
K912241 · JLW
Baxter Healthcare Corp
Chemistry · 30d
Cleared Jun 20, 1991
NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY
K912324 · JLW
Bd Becton Dickinson Vacutainer...
Chemistry · 27d
Cleared Jun 20, 1991
BIPROBE(TM)
K912601 · KNS
C.R. Bard, Inc.
Gastroenterology & Urology · 10d
Cleared Jun 19, 1991
EXTERNAL PACEMAKER ANALYZER MODEL PMA-1
K903966 · DTC
Bio-Tek Instruments, Inc.
Cardiovascular · 295d
Cleared Jun 19, 1991
MGA-IR SIDESTREAM PCO2 MODULE
K904863 · CCK
Marquette Gas Analysis Corp.
Anesthesiology · 233d
Cleared Jun 19, 1991
GASTROSCAN
K905154 · FFX
Medics Instrument Corp.
Gastroenterology & Urology · 216d
Cleared Jun 19, 1991
KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II
K905313 · DSP
Kontron Instruments, Inc.
Cardiovascular · 203d