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
148729–148752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1985
ELECTRO-CAUTERY KNIFE CLEANER 6000 1
K852184 · HAM
Dlp, Inc.
General & Plastic Surgery · 15d
Cleared Jun 04, 1985
MCCOY GENCELLS
K852204 · KIR
Genus Diagnostics
Pathology · 14d
Cleared Jun 04, 1985
RMK GENCELLS CULTURE SYSTEM
K852205 · KIR
Genus Diagnostics
Pathology · 14d
Cleared Jun 04, 1985
HEP-2 GENCELLS
K852206 · KIR
Genus Diagnostics
Pathology · 14d
Cleared Jun 04, 1985
CELLGRO
K852288 · KIT
Mediatech, Inc.
Pathology · 6d
Cleared Jun 03, 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843940 · KWA
Waldemar Link GmbH & Co. KG
Orthopedic · 237d
Cleared Jun 03, 1985
LINK CEMENTLESS SCREW-IN ACETABULAR CUP
K843950 · KWA
Waldemar Link GmbH & Co. KG
Orthopedic · 237d
Cleared Jun 03, 1985
INTEGRITY EYE DROP GUIDE
K851908
Integrity Optics, Inc.
Ophthalmic · 33d
Cleared Jun 03, 1985
AST ASPARTATE AMINOTRANSFERASE REAGENT
K851994 · CIT
Alpkem Corp.
Chemistry · 27d
Cleared Jun 03, 1985
PENNINE DERBY YANKAUER
K852079 · BSY
Pennine Medical , Ltd.
Anesthesiology · 21d
Cleared Jun 03, 1985
PENNINE SUCTION CATHETERS
K852080 · BSY
Pennine Medical , Ltd.
Anesthesiology · 21d
Cleared Jun 03, 1985
CLINICAL WIDEFIELD SPECULAR MICRISCOPE 500
K852150 · HRM
Keeler Instruments, Inc.
General & Plastic Surgery · 17d
Cleared May 31, 1985
EVOMATIC 8000/4000
K843815 · GWF
Dantec Electronics, Inc.
Neurology · 245d
Cleared May 31, 1985
CORNEAL LIGHT SHIELD
K850270 · HRM
Mentor O & O, Inc.
General & Plastic Surgery · 128d
Cleared May 31, 1985
MYOMETER EMG BIOFEEDBACK DEVICE
K850849 · HCC
Physio Technology, Inc.
Neurology · 91d
Cleared May 31, 1985
AXON II BRAND OF DUAL CHANNEL TENS
K850860 · GZJ
Cassandra Electronics Corp.
Neurology · 91d
Cleared May 31, 1985
CRESTLINE CB BEHIND-THE-EAR HEARING AID
K850981 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 81d
Cleared May 31, 1985
DELFIA HTSH KIT
K851120 · JLW
Lkb Instruments, Inc.
Chemistry · 73d
Cleared May 31, 1985
ELECTRO-NERVE STIMULATOR DISCO B9 TENS
K851191 · GZJ
Biomedical Life Systems, Inc.
Neurology · 91d
Cleared May 31, 1985
CILCO/UNITED SONICS PHACE PF-9000
K851209 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
UNITED SONICS PHACO MODULE, DF-35
K851210 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
UNITED SONICS PACO SYSTEM MODEL 3000
K851212 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
MID LABS MVSXI
K851298 · HQC
United Sonics, Inc.
Ophthalmic · 66d
Cleared May 31, 1985
OMNIMED CLAMP
K851654 · HXD
Omni Intl., Inc.
General & Plastic Surgery · 39d