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
140305–140328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1987
OMEGA BIVALVE NASAL SPLINTS
K871073 · FYI
Omega Silicone, Inc.
General & Plastic Surgery · 54d
Cleared May 11, 1987
BARD EMS SYSTEM 6000 E.S.U.
K871435 · HAM
C.R. Bard, Inc.
General & Plastic Surgery · 28d
Cleared May 11, 1987
THERMOMETER SHEATHS
K871465 · FLL
Abco Dealers, Inc.
General Hospital · 27d
Cleared May 11, 1987
SOLOLIFT - PATIENT TRANSFER STRETCHER
K871475 · FMR
Adel Medical , Ltd.
General Hospital · 27d
Cleared May 08, 1987
EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
K870387 · BTR
American Pharmaseal Div. Ahsc
Anesthesiology · 98d
Cleared May 08, 1987
A1-A2 AMBULATORY EEG CASSETTE RECORDER
K870432 · GWQ
Grass-Telefactor Product Group
Neurology · 94d
Cleared May 08, 1987
TRACH MATE TRACHEAL TUBE
K870470 · BTR
Mccormick Laboratories, Inc.
Anesthesiology · 94d
Cleared May 08, 1987
CSI/3D
K870513 · JAK
Columbia Scientific, Inc.
Radiology · 92d
Cleared May 08, 1987
IMAGEN HERPES SIMPLEX VIRUS (HSV) TYPING TEST
K870602 · GQN
Boots-Celltech Diagnostics, Inc.
Microbiology · 86d
Cleared May 08, 1987
FNA THYROID BIOPSY KIT
K870863 · FMI
Flint Laboratories Div. Travenol
General Hospital · 66d
Cleared May 08, 1987
KM-4(TM) METAL-BACKED ACETABULAR CUP
K870867 · JDL
Kirschner Medical Corp.
Orthopedic · 66d
Cleared May 08, 1987
COMPASS STEREOTACTIC POSITIONING SYSTEM
K871046 · HAW
Stereotactic Medical Systems, Inc.
Neurology · 52d
Cleared May 08, 1987
SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380
K871189 · KFZ
Sunbeam Appliance Service Co.
Anesthesiology · 45d
Cleared May 08, 1987
GRATICULE
K871214 · IYE
Mick Radio-Nuclear Instruments, Inc.
Radiology · 43d
Cleared May 08, 1987
SERVO NEBULIZER 945 SIEMENS-ELEMA AB
K871293 · CAF
Siemens Elema AB
Anesthesiology · 38d
Cleared May 08, 1987
(FPIA) ASSAY BUFFER
K871486 · JJF
Windsor Laboratories, Inc.
Chemistry · 23d
Cleared May 08, 1987
BANDAGES CATALOG NUMBER: 101 TO 220
K871495 · NAD
I M, Inc.
General & Plastic Surgery · 22d
Cleared May 08, 1987
PERSONNEL PROTECTIVE SHIELD
K871502 · KPY
Cis-Us, Inc.
Radiology · 21d
Cleared May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO - TWO VIAL
K871508 · CDT
Trace Scientific , Ltd.
Chemistry · 22d
Cleared May 08, 1987
RESUBMITTED TRIGLYCERIDE GPO REAGENT (SINGLE VIAL)
K871509 · CDT
Trace Scientific , Ltd.
Chemistry · 22d
Cleared May 08, 1987
DAHLBERG MODEL UH IN-THE-EAR HEARING AID
K871524 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 18d
Cleared May 08, 1987
RODRIGUEZ NAIL
K871608 · HSB
Richards Medical Co., Inc.
Orthopedic · 14d
Cleared May 08, 1987
PREFILLED STERILE WATER FOR INHALATION, USP
K871618 · BTT
Automatic Liquid Packaging, Inc.
Anesthesiology · 11d
Cleared May 08, 1987
IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR
K871664 · JIX
Instrumentation Laboratory CO
Chemistry · 10d