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
145297–145320 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1986
WELLCOGEN BACTERIAL ANTIGEN KIT
K854852 · GTJ
Wellcome Diagnostics
Microbiology · 61d
Cleared Feb 04, 1986
SYSTEMS OF SIGHT LOW VISION EYEWARE
K854854 · HOI
Int'L Eye Care, Inc.
Ophthalmic · 61d
Cleared Feb 04, 1986
EVEREST & JENNINGS TRADITION-STANDARD BED L109684&
K854867 · FNL
Carrom Healthcare, Inc.
General Hospital · 61d
Cleared Feb 04, 1986
INTRAOCULAR PRESSURE REDUCER
K854873 · LCR
Mira, Inc.
Toxicology · 62d
Cleared Feb 04, 1986
SUNGLASSES
K854879 · HQY
Jarnger Trading Co., Ltd.
Ophthalmic · 60d
Cleared Feb 04, 1986
CARROM CARELIFE SERIES 40000 MODULAR BES SYSTEM
K854937 · FNL
Carrom Healthcare, Inc.
General Hospital · 56d
Cleared Feb 04, 1986
MODEL 9500 ARGON, KRYPTON & DYE SURGICAL LASER SYS
K854949 · HQF
CooperVision, Inc.
Ophthalmic · 56d
Cleared Feb 04, 1986
OPTRONICS CONTRAST ACUITY TESTER
K854983 · HOX
Optronics, Inc.
Ophthalmic · 54d
Cleared Feb 04, 1986
BARTELL SMALL INCISION LENS GLIDE
K854994 · KYB
Microtech, Inc.
Ophthalmic · 54d
Cleared Feb 04, 1986
DURAHESIVE WAFER WITH FLANGE
K855018 · EXB
Convatec, A Division of E.R. Squibb &...
Gastroenterology & Urology · 50d
Cleared Feb 04, 1986
ACROMED NESTED BONE PLATE
K855224 · JEY
Buckman Co., Inc.
Orthopedic · 36d
Cleared Feb 04, 1986
MODIFICATION ASAHI NEW PAN-SERIES HEMOFILTERS
K855251 · KDI
Advocacy International, Ltd.
Gastroenterology & Urology · 36d
Cleared Feb 04, 1986
BARRAQUER-KRUMEICH REFRACTIVE SET
K860001 · HNO
American Medical Optics
Ophthalmic · 33d
Cleared Feb 04, 1986
PARENTERAL ADMINISTRATION SET
K860201 · FPA
Migada, Ltd.
General Hospital · 13d
Cleared Feb 03, 1986
TRANSTRACHEAL SYSTEM-SCOOP-INSERTION TRAY-CATHETER
K854252 · BTO
Transtracheal Systems
Anesthesiology · 104d
Cleared Jan 31, 1986
MIX EVAC II
K854077 · JDZ
Stryker Corp.
Orthopedic · 116d
Cleared Jan 30, 1986
SATALEC PIEZOTEC
K852525 · ELC
Spelna, Inc.
Dental · 230d
Cleared Jan 30, 1986
STARPORT MODEL H3300AA
K852648 · IYX
General Electric Co.
Radiology · 223d
Cleared Jan 30, 1986
CORNEO-GAGE TWO
K852862 · IYO
Sonogage, Inc.
Radiology · 206d
Cleared Jan 30, 1986
MODEL RF-TENS-4 TRANSCUTANEOUS ELEC. NERVE STIMULA
K853885 · GZJ
Uniking Intl. Corp.
Neurology · 133d
Cleared Jan 30, 1986
HOMECARE CLINICS INFRAHEAT #230
K854151 · ILY
Nelkin/Piper Intl.
Physical Medicine · 111d
Cleared Jan 30, 1986
PHOENIX U.V.A. SUNTAN BEDS
K854594 · FTC
Phoenix U.V.A. , Ltd.
General & Plastic Surgery · 73d
Cleared Jan 30, 1986
JACKSON RARE EARTH MAGNETIC ATTACHMENT
K854633 · EGG
Solid State Innovations, Inc.
Dental · 72d
Cleared Jan 30, 1986
SUNTAINNING BOOTH
K854707 · FTC
David Connell
General & Plastic Surgery · 71d