FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
90481–90504 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1998
YEUNG ENDOSCOPIC SPINE SYSTEM
K973405 · HRX
Richard Wolf Medical Instruments Corp.
Orthopedic · 185d
Cleared Mar 13, 1998
WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL...
K973474 · MHX
Witt Biomedical Corporation
Cardiovascular · 182d
Cleared Mar 13, 1998
VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA
K973628 · JJF
Vital Scientific N.V.
Chemistry · 170d
Cleared Mar 13, 1998
LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING
K973664 · LYY
Evergrade Healthcare Products Sdn Bhd
General Hospital · 169d
Cleared Mar 13, 1998
PS-UNIT CASSETTE/SERUM AND URINE COMBO HCG
K974009 · JHI
International Newtech Development, Inc.
Chemistry · 143d
Cleared Mar 13, 1998
SMARTTEX
K974557 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 98d
Cleared Mar 13, 1998
COAXIAL DILATOR SET
K974640 · DRE
Boston Scientific Corp
Cardiovascular · 88d
Cleared Mar 13, 1998
COMBICATH CATHETER
K974642 · EOQ
Plastimed Laboratoire Pharmaceutique
Ear, Nose, Throat · 88d
Cleared Mar 13, 1998
SILICONE ELASTOMER SHEETING
K974653 · MIB
Specialty Surgical Products, Inc.
General & Plastic Surgery · 88d
Cleared Mar 13, 1998
ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE,...
K974670 · EFB
Athena Technology, Inc.
Dental · 88d
Cleared Mar 13, 1998
MSI SURGICAL DRAPES
K974672 · KKX
Medical Specialty Innovations, Inc....
General Hospital · 88d
Cleared Mar 13, 1998
AESCULAP ABC CERVICAL PLATING SYSTEM
K974706 · KWQ
Aesculap, Inc.
Orthopedic · 87d
Cleared Mar 13, 1998
HOWMEDICA(R) FULLY THREADED SCREWS
K974720 · HSB
Howmedica, Inc.
Orthopedic · 85d
Cleared Mar 13, 1998
SYNERGY CLOSED VARIABLE LOCKING SCREW (VLS), PART OF THE CROSS...
K974749 · MNH
Cross Medical Products, Inc.
Orthopedic · 84d
Cleared Mar 13, 1998
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE...
K974773 · DQX
Guidant Corp.
Cardiovascular · 81d
Cleared Mar 13, 1998
DRG MF TITANIUN ALLOY BONE SCREW 1.0MM, 1.2MM, 1.3MM, 1.5MM, 1.7MM, 2.0MM, 2.4MM
K974817 · DZL
Doctor'S Research Group, Inc.
Dental · 80d
Cleared Mar 13, 1998
LATEX EXAMINATION GLOVE POWDER FREE
K974870 · LYY
Smart Glove Corp. Sdn Bhd
General Hospital · 74d
Cleared Mar 13, 1998
GAS MODULE II, MODEL 0998-00-0143
K974903 · CBS
Datascope Corp.
Anesthesiology · 72d
Cleared Mar 13, 1998
NITRILE PRE-POWDERED EXAMINATION GLOVES
K974907 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 72d
Cleared Mar 13, 1998
M500-100 SHARPS CONTAINER
K980003 · FMI
Imagination Medical, Inc.
General Hospital · 70d
Cleared Mar 13, 1998
SUPERGLOVES LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
K980071 · LYY
Supermax Latex Products Sdn. Bhd.
General Hospital · 64d
Cleared Mar 13, 1998
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL...
K980163 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 56d
Cleared Mar 13, 1998
POWDERFREE LATEX EXAMINATION GLOVES
K980167 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 56d
Cleared Mar 13, 1998
POWDERFREE LATEX EXAMINATION GLOVES
K980194 · LYY
Besglove Medicare Sdn. Bhd.
General Hospital · 52d