FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

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

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175,820 results
118633–118656 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 13, 1992
D7113 ANVIL CUTTER AND D7112 AIR-POWERED HANDLE
K915745 · HQE
Storz Instrument Co.
Ophthalmic · 81d
Cleared Mar 13, 1992
POOLE TIP SUCTION PROBE
K915762 · GCI
O.R. Concepts, Inc.
General & Plastic Surgery · 80d
Cleared Mar 13, 1992
MIS ELECTROSURGICAL ELECTRODES
K915788 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 80d
Cleared Mar 13, 1992
DRG CEMETED STEM
K920003 · JDI
Intermedics Orthopedics
Orthopedic · 71d
Cleared Mar 13, 1992
IL TEST IMMUNOGLOBULIN G (IGG)
K920006 · CGM
Instrumentation Laboratory CO
Immunology · 71d
Cleared Mar 13, 1992
IL TEST COMPLEMENT 4
K920010 · DBI
Instrumentation Laboratory CO
Immunology · 71d
Cleared Mar 13, 1992
ADL 400 ND
K920106 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 64d
Cleared Mar 13, 1992
ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR
K920107 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 64d
Cleared Mar 13, 1992
HEALTHTEST RHEUMATOID FACTOR ASSAY
K920220 · DHR
Akers Research Corp.
Immunology · 57d
Cleared Mar 13, 1992
HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY
K920221 · KTN
Akers Research Corp.
Immunology · 57d
Cleared Mar 13, 1992
LUMBAR CPM
K920519 · BXB
Rehabilitative Resources, Inc.
Physical Medicine · 39d
Cleared Mar 13, 1992
SYVA EMIT II METHADONE ASSAY
K920751 · DJR
Syva Co.
Toxicology · 23d
Cleared Mar 13, 1992
HEMOSTAT, SURGICAL (VARIOUS TYPES)
K920883 · EMD
S.T.S Instruments
Dental · 16d
Cleared Mar 12, 1992
HEARING AID (ALL-IN-THE-EAR)
K912399 · ESD
Carlson'S Heritage Hearing Aid Center
Ear, Nose, Throat · 287d
Cleared Mar 12, 1992
STERILE PLASTIC DRAPE
K913408 · KKX
Acacia Laboratories, Inc.
General Hospital · 226d
Cleared Mar 12, 1992
AESCULAP TITANIUM BONE PLATES
K913730 · KWQ
Aesculap, Inc.
Orthopedic · 205d
Cleared Mar 12, 1992
SCM-3 AND ACCESSORIES
K914921 · IKY
Gaymar Industries, Inc.
General Hospital · 129d
Cleared Mar 12, 1992
3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
K915390 · FPA
Baxter Healthcare Corp
General Hospital · 104d
Cleared Mar 12, 1992
AD-HEAR
K915794 · ESD
Hearing Components, Inc.
Ear, Nose, Throat · 79d
Cleared Mar 12, 1992
SHOPRIDER - TE889
K920654 · INI
Pride Health Care, Inc.
Physical Medicine · 29d
Cleared Mar 11, 1992
DATASCOPE SYSTEM 95
K912629 · DSP
Datascope Corp.
Cardiovascular · 268d
Cleared Mar 11, 1992
YASARGIL ANEURYSM CLIPS, MODIFICATION
K913765 · HCH
Aesculap, Inc.
Neurology · 202d
Cleared Mar 11, 1992
SYSTEM 90 AND SYSTEM 90T
K913847 · DSP
Datascope Corp.
Cardiovascular · 197d
Cleared Mar 11, 1992
GAS SAMPLING INTERFACES
K914337 · CCK
Vital Signs, Inc.
Anesthesiology · 166d