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
94369–94392 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1997
CANON TX-10 TONOMETER
K963079 · HKX
Canon USA, Inc.
Ophthalmic · 208d
Cleared Mar 03, 1997
LEGIONELLA IGG/IGM ELISA TEST SYSTEM
K963318 · LHL
Armkel, LLC
Microbiology · 192d
Cleared Mar 03, 1997
IMZ 2000 INTERLOCK 12/3 - CYLINDER DENTAL IMPLANT SYSTEM
K963495 · DZE
Imz, GmbH
Dental · 181d
Cleared Mar 03, 1997
IMZ 2000 INTERLOCK 12/3 - SCREW
K963522 · DZE
Imz, GmbH
Dental · 181d
Cleared Mar 03, 1997
KENLOR H. PYLORI CONTROL SERUM
K964014 · LYR
Kenlor Industries, Inc.
Microbiology · 147d
Cleared Mar 03, 1997
PROCEDURE SPECIFIC KITS
K964168 · FXX
Sage Products, Inc.
General Hospital · 137d
Cleared Mar 03, 1997
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
K964698 · JKA
Andwin Scientific
General Hospital · 101d
Cleared Mar 03, 1997
RADIACARE ORAL WOUND RINSE
K964852 · OLR
Carrington Laboratories, Inc.
General & Plastic Surgery · 90d
Cleared Mar 03, 1997
MARK 20 AND MARK 25 HAND ENGINE CONTROLLER
K964860 · EBW
Bell Intl., Inc.
Dental · 89d
Cleared Mar 03, 1997
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
K964871 · FEB
Biosearch Medical Products, Inc.
General Hospital · 88d
Cleared Mar 03, 1997
MMB CALIBRATOR
K970336 · JIT
Dade Chemistry Systems, Inc.
Chemistry · 33d
Cleared Mar 03, 1997
THYROID STIMULATING HORMONE METHOD
K970393 · JLW
Dade Chemistry Systems, Inc.
Chemistry · 28d
Cleared Mar 03, 1997
ABBOTT HCG SERUM CONTROLS
K970527 · JJX
Abbott Laboratories
Chemistry · 20d
Cleared Feb 28, 1997
DELTA
K945117 · FLE
Pelton & Crane Co.
General Hospital · 864d
Cleared Feb 28, 1997
TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
K953076 · MRW
Sofamor Danek USA,Inc.
Orthopedic · 609d
Cleared Feb 28, 1997
AIRSEP NEWLIFE DUAL SIX OXYGEN CONCENTRATOR (MODIFICATION)
K960309 · CAW
Airsep Corp.
Anesthesiology · 420d
Cleared Feb 28, 1997
THERA-MIST NEBULIZER MODEL-P3000
K962534 · CAF
Pegasus Research Corp.
Anesthesiology · 245d
Cleared Feb 28, 1997
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
K963120 · DRO
Marquette Electronics, Inc.
Cardiovascular · 200d
Cleared Feb 28, 1997
CARDIACMONITOR
K963375 · DXH
Vision Electronics
Cardiovascular · 185d
Cleared Feb 28, 1997
MOBILE MEDICAL MONITOR (M3(A))
K963576 · DRT
Scientific Applications
Cardiovascular · 175d
Cleared Feb 28, 1997
QUIKSTRIP ONESTEP MARIJUANA (THC) TEST
K963654 · LDJ
Syntron Bioresearch, Inc.
Toxicology · 169d
Cleared Feb 28, 1997
CYBERLASE CO2 LASER SYSTEM
K964353 · GEX
Nidek, Inc.
General & Plastic Surgery · 119d
Cleared Feb 28, 1997
MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A
K964820 · MOS
Us Asia Instruments, Inc.
Radiology · 88d
Cleared Feb 28, 1997
ISOCAM II (DUAL HEAD GAMMA CAMERA)
K964834 · KPS
Park Medical Systems, Inc.
Radiology · 88d