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

Filters: Cleared only ×
175,820 results
145417–145440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 06, 1986
IMIPENEM SUSCEPTIBILITY POWDER
K855071 · JTT
Merck, Sharp & Dohme
Microbiology · 77d
Cleared Mar 06, 1986
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
K855106 · JTT
Bd Becton Dickinson Vacutainer...
Microbiology · 73d
Cleared Mar 06, 1986
DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLES
K855111 · ELW
Pacific Union Dental, Inc.
Dental · 73d
Cleared Mar 06, 1986
DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYS
K855112 · ELW
Pacific Union Dental, Inc.
Dental · 73d
Cleared Mar 06, 1986
FLOSS HOLDER (PLASTIC)
K855113 · JES
Pacific Union Dental, Inc.
Dental · 73d
Cleared Mar 06, 1986
FLEXOR FLEXIBLE ROANE TIP ENDODONTIC FILE
K855136 · EKS
Union Broach, Div. Moyco Industries,...
Dental · 73d
Cleared Mar 06, 1986
IMIPENEM 10 MCG SENSITIVITY DISCS
K855207 · JTT
Difco Laboratories, Inc.
Microbiology · 66d
Cleared Mar 06, 1986
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
K860031 · JTT
Organon Teknika Corp.
Microbiology · 59d
Cleared Mar 06, 1986
ISO-MAMMO
K860129 · IZH
Philips Medical Systems (Cleveland),...
Radiology · 51d
Cleared Mar 06, 1986
MODEL 446 & 447 MOUTH TO MASK RESUSCITATOR
K860180 · BTM
Life Support Products, Inc.
Anesthesiology · 44d
Cleared Mar 06, 1986
BT-795/P AUTOMATED AUTOTRANS
K860306 · CAC
Electromedics, Inc.
Hematology · 37d
Cleared Mar 06, 1986
SWEET DREEMS SIMULATOR
K860596 · FMS
Sweet Dreams, Inc.
General Hospital · 15d
Cleared Mar 06, 1986
KULTSURE (CATALOGUE NO. M200)
K860655 · LIO
Ncs Diagnostics, Inc.
Microbiology · 13d
Cleared Mar 06, 1986
KODAK X-OMAT PROCESSOR, MODEL ME-3
K860666 · IXW
Eastman Kodak Company
Radiology · 10d
Cleared Mar 06, 1986
KODAK T-MAT M FILM SO-245
K860754 · IXA
Eastman Kodak Company
Radiology · 6d
Cleared Mar 06, 1986
KODAK MIN-R FAST SCREEN SO-459
K860755 · EAM
Eastman Kodak Company
Radiology · 6d
Cleared Mar 05, 1986
MONOFIXATEUR
K854336 · HWC
Ortopedia GmbH
Orthopedic · 128d
Cleared Mar 05, 1986
SKD ELECTROCHEMICAL SYSTEM (ECS)
K854723 · CEM
Smithkline Diagnostics, Inc.
Chemistry · 103d
Cleared Mar 05, 1986
INTRAOCULAR FORCEPS & SCISSORS
K854869 · HNR
Mira, Inc.
Ophthalmic · 91d
Cleared Mar 05, 1986
LINK METAL-BACKED ACETABULAR CUPS
K854935 · JDL
Link America, Inc.
Orthopedic · 85d
Cleared Mar 05, 1986
STORZ E9040 & E9046 DIAMOND KNIVES
K855050 · HNN
Storz Instrument Co.
Ophthalmic · 78d
Cleared Mar 05, 1986
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
K855079 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 76d
Cleared Mar 05, 1986
CPK (UV) REAGENT KIT
K855188 · JHS
Technostics Intl.
Chemistry · 69d
Cleared Mar 05, 1986
SYSTEMS PLUS
K860014 · HQE
United Surgical Corp.
Ophthalmic · 61d