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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
148297–148320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 02, 1985
TABLE ACCESSORIES, OPERATING ROOM
K852332 · BWN
Scholten Surgical Instruments, Inc.
General & Plastic Surgery · 32d
Cleared Jul 02, 1985
SPLINTS(ALL TYPE)
K852558 · FYH
The Huxley Instrument Corp.
General Hospital · 15d
Cleared Jul 02, 1985
BONE PIN CUTTER-18 INCH
K852559
The Huxley Instrument Corp.
General & Plastic Surgery · 15d
Cleared Jul 01, 1985
SONTEC II
K844126 · IPF
Sontec, Inc.
Physical Medicine · 251d
Cleared Jul 01, 1985
BDS-3 BEAM DATA SCANNER
K844620 · LHO
Varian Assoc., Inc.
Radiology · 216d
Cleared Jul 01, 1985
RFA-7 RADIATION FIELD ANALYZER
K845007 · LHO
Varian Assoc., Inc.
Radiology · 187d
Cleared Jul 01, 1985
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K850648 · BSZ
Ohmeda Medical
Anesthesiology · 132d
Cleared Jul 01, 1985
AUTOMOVE/OMNISTIM IV-ELECTRICAL MUSCLE STIMULATOR
K850850 · IPF
Physio Technology, Inc.
Physical Medicine · 122d
Cleared Jul 01, 1985
MYOCARE PLUS DUAL CHANNEL STIMULATOR
K851046 · IPF
3M Company
Physical Medicine · 109d
Cleared Jul 01, 1985
SPIRO SCAN
K851135 · BZG
Brentwood Instruments, Inc.
Anesthesiology · 102d
Cleared Jul 01, 1985
THE ENDURO
K851227 · IOR
Wheel Ring, Inc.
Physical Medicine · 97d
Cleared Jul 01, 1985
ALEXIS
K851261 · ITI
Intex Research & Development Center
Physical Medicine · 95d
Cleared Jul 01, 1985
ABCO PLASTIC UTENSILS
K851309 · KTC
Abco Dealers, Inc.
Physical Medicine · 90d
Cleared Jul 01, 1985
MODEL BION 2/TYPE 90 ROOM IONIZER
K851358 · FRF
Medicor USA , Ltd.
General Hospital · 88d
Cleared Jul 01, 1985
HEARING AID(ALL IN THE EAR)
K851427 · ESD
Woodard Hearing Aid Center
Ear, Nose, Throat · 82d
Cleared Jul 01, 1985
ACCURATECARE I & ACCURATECARE II
K851511 · GZJ
Sunnex, Inc.
Neurology · 77d
Cleared Jul 01, 1985
SKULL MOUNTED STEREOTACTIC SURGICAL DEVICE
K851659 · HAW
Medco Products, Co., Inc.
Neurology · 69d
Cleared Jul 01, 1985
500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA
K851708 · EMG
Artiberia
Dental · 67d
Cleared Jul 01, 1985
2250/1 TO 2285/2 VARIOUS COTTON TWEEZERS
K851728 · GEN
Artiberia
General & Plastic Surgery · 67d
Cleared Jul 01, 1985
VACUUM COMPRESSION INJECTOR
K851809 · KZE
Uci Corp.
General Hospital · 66d
Cleared Jul 01, 1985
DAHLBERT MODEL DE BEHING-THE-EAR HEARING AID
K851868 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 63d
Cleared Jul 01, 1985
MAX-I-PROBE HANDPIECE
K851944 · EIC
Solo Pak Laboratories
Dental · 59d
Cleared Jul 01, 1985
PHOTO CURING LIGHT
K852151 · EBF
Dentsply Intl.
Dental · 45d
Cleared Jul 01, 1985
SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.
K852180
Surgidyne, Inc.
General & Plastic Surgery · 42d