FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
146401–146424 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1985
H-H HUNTER PASSIVE TENDON IMPLANT
K853436 · HXR
Holter-Hausner Intl.
General & Plastic Surgery · 62d
Cleared Oct 16, 1985
H-H HUNTER TENDON ROD
K853437
Holter-Hausner Intl.
Orthopedic · 62d
Cleared Oct 16, 1985
POLYCARB WATER SET
K853447 · EMA
Pulpdent Corp. of America
Dental · 61d
Cleared Oct 16, 1985
PEE WEE THERMOMETERS
K853515 · FQZ
Joel R.L. Ehren Kranz
General Hospital · 55d
Cleared Oct 16, 1985
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100
K853786 · CCE
American Bentley
Anesthesiology · 36d
Cleared Oct 16, 1985
NEOGUARD REFLECTOR
K853794 · FMT
Cas Medical Systems, Inc.
General Hospital · 35d
Cleared Oct 16, 1985
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
K853820 · KGX
Abco Dealers, Inc.
General & Plastic Surgery · 34d
Cleared Oct 16, 1985
LH/FSH RADIOIMMUNOASSAY KIT
K853837 · CEP
Bioclinical Group
Chemistry · 30d
Cleared Oct 16, 1985
JMS LCC INSULIN SYRINGE
K853838 · FMF
Jms Co., Ltd.
General Hospital · 72d
Cleared Oct 16, 1985
V-TREND ASO PLUS LATEX TEST
K853857 · GTQ
Texas Immunology, Inc.
Microbiology · 30d
Cleared Oct 16, 1985
ATTENDS DISPOS. UNDERPAD
K853880 · KME
Procter & Gamble Mfg. Co.
General Hospital · 28d
Cleared Oct 16, 1985
OHMEDA OXYGEN BLENDER
K853905 · BZR
Ohmeda Medical
Anesthesiology · 26d
Cleared Oct 16, 1985
LASE SYSTEM II
K853927
James L. Geraci & Associates, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 1985
OMNI-TRACT CHEST WALL & LUNA RETRACTOR
K853947 · GAD
Minnesota Scientific, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 1985
MINNESOTA SCIENTIFIC, INC. OMNI-BEAM
K853948 · HBI
Minnesota Scientific, Inc.
General & Plastic Surgery · 22d
Cleared Oct 16, 1985
DEMAND ACID PHOSPHATASE REAGENT
K853949 · CKB
Cooper Biomedical, Inc.
Chemistry · 22d
Cleared Oct 16, 1985
WESCOR MODEL 3700 WEBSTER SWEAT INDUCER
K853973 · KTB
Wescor, Inc.
Physical Medicine · 20d
Cleared Oct 16, 1985
CANON X-RAY 35MM CINE CAMERA CSI-35
K853983 · IZJ
Canon USA, Inc.
Radiology · 19d
Cleared Oct 16, 1985
CANON X-RAY IMAGE DISTRIBUTOR
K853984 · JAA
Canon USA, Inc.
Radiology · 19d
Cleared Oct 15, 1985
MEDCYC SUPERCONDUCT ISOCEN NEUTRON THERAPY SYS
K852804 · IWL
Medcyc. Corp.
Radiology · 104d
Cleared Oct 15, 1985
THE FIELDMASTER MODEL 275
K852936 · HPT
Synemed, Inc.
Ophthalmic · 97d
Cleared Oct 15, 1985
COBURN I/A SYSTEM
K853457 · HQE
Coburn Optical Ind., Inc.
Ophthalmic · 60d
Cleared Oct 15, 1985
ORC ORACLE
K853668 · HLQ
Optical Radiation Corp.
Ophthalmic · 42d
Cleared Oct 15, 1985
ZEISS OPERATING KERATOMETER
K853723 · HLQ
Carl Zeiss, Inc.
Ophthalmic · 40d