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
148705–148728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 05, 1985
SPQ TEST SYSTEM FOR C-REACTIVE PROTEIN
K851842 · DCK
Atlantic Antibodies
Immunology · 40d
Cleared Jun 05, 1985
STERILE ENDOTRACHEAL BRUSHES
K851851
Biological & Environmental Control...
Cardiovascular · 40d
Cleared Jun 05, 1985
A COMPANY BRASS SEPARATING RINGS
K851878 · DZC
A Company, Inc.
Dental · 37d
Cleared Jun 05, 1985
BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD
K852019 · EAP
Belmont Equipment Corp.
Radiology · 28d
Cleared Jun 05, 1985
ACC CROSS CYLINDERS
K852056 · HPC
Ascon Medical Instruments, Ltd.
Ophthalmic · 27d
Cleared Jun 05, 1985
ATF 101 TRAIL FRAME
K852126 · HPA
Ascon Medical Instruments, Ltd.
Ophthalmic · 21d
Cleared Jun 04, 1985
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
K844762 · GTJ
Wellcome Diagnostics
Immunology · 179d
Cleared Jun 04, 1985
NOMAD TM-3400
K850109 · GWF
Tracor Northern, Inc.
Neurology · 141d
Cleared Jun 04, 1985
TUTTNAUER PRE-VACUUM AUTOCLAVE
K850264 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 132d
Cleared Jun 04, 1985
CANAL FINDER
K850294 · EGS
Roseburg SA
Dental · 131d
Cleared Jun 04, 1985
FLEXIBLE FIBEROPTIC ENDOSCOPE
K850393
Microvasive
Gastroenterology & Urology · 123d
Cleared Jun 04, 1985
SARTORIUS AQUASART SM 40035 - DIALYSATE SYS
K850435 · FKR
Sartorius Filters, Inc.
Gastroenterology & Urology · 120d
Cleared Jun 04, 1985
TA-20 AUTOMATIC INDUSTIRAL AUDIOMETER
K851015 · EWO
Teledyne Avionics Div. of Teledyne
Ear, Nose, Throat · 84d
Cleared Jun 04, 1985
TENSMED II
K851063 · GZJ
Intermedics, Inc.
Neurology · 81d
Cleared Jun 04, 1985
ECONOMY 400 CWS WITH PVC DRAINS
K851084 · GCY
C.R. Bard, Inc.
General & Plastic Surgery · 78d
Cleared Jun 04, 1985
INCISION DRAIN
K851196 · GCD
Sil-Med Corp.
General & Plastic Surgery · 70d
Cleared Jun 04, 1985
BAC-T-SCREEN
K851399 · JXA
Marion Laboratories, Inc.
Microbiology · 56d
Cleared Jun 04, 1985
S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP
K851421 · LPH
Joint Medical Products Corp.
Orthopedic · 55d
Cleared Jun 04, 1985
HERACOR SYSTEM HERACOR PLATINUM FOIL, BLENDGOLD NE
K851648 · EJS
Heraeus Dental Gold Corp.
Dental · 43d
Cleared Jun 04, 1985
PROSTHESIS OR SURGICAL PADS
K851668 · GBI
Virginia Hall, Inc.
General & Plastic Surgery · 42d
Cleared Jun 04, 1985
QUALITONE STOCK CANAL AID
K851970 · ESD
Qualitone
Ear, Nose, Throat · 28d
Cleared Jun 04, 1985
LYFO-KWIK OMI KIT
K851978 · JSS
Micro-Bio-Logics
Microbiology · 28d
Cleared Jun 04, 1985
DRI-FORM PSEUDOMONAS AGAR F
K852064 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 22d
Cleared Jun 04, 1985
IDS RAPID E PLUS SYSTEM
K852110 · JSS
Innovative Diagnostic Systems, Inc.
Microbiology · 20d