Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
69193–69216 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 2004
SHIMADZU IMAGE AMPLIFIER, MODEL IA-16L/HS
K040870 · JAA
Shimadzu Corp.
Radiology · 45d
Cleared May 17, 2004
WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
K040918 · JJX
Wako Chemicals USA, Inc.
Chemistry · 39d
Cleared May 17, 2004
LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS
K040927 · JJX
Cliniqa Corporation
Chemistry · 38d
Cleared May 17, 2004
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
K041058 · QPB
Misonix, Inc.
General & Plastic Surgery · 24d
Cleared May 17, 2004
SIEMENS ENHANCED IMAGING SYSTEM
K041166 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 13d
Cleared May 17, 2004
URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM
K041176 · OTN
Sofradim Production
Gastroenterology & Urology · 12d
Cleared May 17, 2004
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200
K041228 · DXN
Mytech Technology Co., Ltd.
Cardiovascular · 7d
Cleared May 14, 2004
ENERTRON CPR JACK
K024215 · DRM
Enertron Engineering Co.
Cardiovascular · 511d
Cleared May 14, 2004
LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER
K030425 · JEY
Walter Lorenz Surgical, Inc.
Dental · 459d
Cleared May 14, 2004
BITESTRIP
K030869 · KZM
S.L.P. , Ltd.
Dental · 422d
Cleared May 14, 2004
AEQUALIS REVERSED SHOULDER PROSTHESIS
K030941 · PHX
Tornier
Orthopedic · 416d
Cleared May 14, 2004
KMC-950 C-ARM MOBILE SYSTEM
K032761 · OWB
United Radiology Systems, Inc.
Radiology · 252d
Cleared May 14, 2004
TABLE TILT DEVICE
K033316 · JAI
Brainlab AG
Radiology · 212d
Cleared May 14, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA...
K033957 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 144d
Cleared May 14, 2004
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
K040017 · KWQ
Aesculap, Inc.
Orthopedic · 129d
Cleared May 14, 2004
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174 · MQM
Roche Diagnostics Corp.
Chemistry · 109d
Cleared May 14, 2004
MYDON C
K040384 · GEX
Wavelight Laser Technologie AG
General & Plastic Surgery · 87d
Cleared May 14, 2004
POLYMER COATED, CHLORINATED, POWDER-FREE LATEX EXAMINATION GLOVES WITH...
K040406 · LYY
Shun Thai Rubber Gloves Industry...
General Hospital · 87d
Cleared May 14, 2004
BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS
K040504 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 77d
Cleared May 14, 2004
MINI GAMMA CAMERA, MODEL MGC-500
K040587 · IYX
Acrorad Co., Ltd.
Radiology · 70d
Cleared May 14, 2004
STEP-TIP CHRONIC HEMODIALYSIS CATHETER
K040666 · MSD
Arrow International, Inc.
Gastroenterology & Urology · 60d
Cleared May 14, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML
K040716 · LON
Becton, Dickinson & CO
Microbiology · 56d
Cleared May 14, 2004
VARELISA HISTONE ANTIBODIES, MODEL 16496
K040810 · LJM
Pharmacia Deutschland GmbH
Immunology · 46d
Cleared May 14, 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040962 · KWQ
Medtronic Sofamor Danek
Orthopedic · 30d