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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82753–82776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 27, 2000
LEICA COLPOSCOPE
K000707 · HEX
Leica Microscopy Systems , Ltd.
Obstetrics & Gynecology · 117d
Cleared Jun 27, 2000
ELECTROSURGICAL ELECTRODE FAMILY
K001151 · GEI
Novasys Medical, Inc.
General & Plastic Surgery · 78d
Cleared Jun 27, 2000
MONARCH II IOL DELIVERY SYSTEM
K001157 · KYB
Alcon Research, Ltd.
Ophthalmic · 78d
Cleared Jun 27, 2000
TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY...
K001180 · DTE
Pace Medical
Cardiovascular · 77d
Cleared Jun 27, 2000
BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
K001258 · FGE
Cordis Corp.
Gastroenterology & Urology · 70d
Cleared Jun 27, 2000
MAC-LAB SYSTEM AND CARDIOLAB EP SYSTEM
K001305 · DQK
General Electric Medical Systems...
Cardiovascular · 64d
Cleared Jun 27, 2000
AARON 2100 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K001382 · GEI
Aaron Medical Industries
General & Plastic Surgery · 56d
Cleared Jun 27, 2000
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · IZL
Shimadzu Corp.
Radiology · 42d
Cleared Jun 26, 2000
MACROPOREDX DISTRACTOR SYSTEM
K000992 · MQN
Macropore Biosurgery, Inc.
Dental · 90d
Cleared Jun 26, 2000
SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM
K001226 · HRX
Smith & Nephew, Inc.
Orthopedic · 70d
Cleared Jun 26, 2000
ADVIA IMS
K001344 · DIH
Bayer Corp.
Chemistry · 60d
Cleared Jun 26, 2000
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
K001569 · JFJ
Sigma Diagnostics, Inc.
Chemistry · 38d
Cleared Jun 23, 2000
VIVANT MEDICAL BIOPSY MARKER SYSTEM
K000278 · FZP
Vivant Medical, Inc.
General & Plastic Surgery · 144d
Cleared Jun 23, 2000
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
K000351 · LYY
Hanwella Rubber Products , Ltd.
General Hospital · 140d
Cleared Jun 23, 2000
UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTED
K000827 · KRR
Walter Abendschein, M.D.
Orthopedic · 101d
Cleared Jun 23, 2000
KLINIDRAPE SURGICAL DRAPES
K000906 · KKX
Molnlycke Health Care, Inc.
General Hospital · 94d
Cleared Jun 23, 2000
OPUS 10 DENTAL DIODE LASER
K000990 · GEX
Opusdent , Ltd.
General & Plastic Surgery · 87d
Cleared Jun 23, 2000
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
K001078 · JDI
Sulzer Orthopedics, Inc.
Orthopedic · 80d
Cleared Jun 23, 2000
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP)...
K001107 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 79d
Cleared Jun 23, 2000
AUDIO TECHNOLOGIES S:R.1
K001142 · ETB
Audio Technologies S.R.L.
Ear, Nose, Throat · 74d
Cleared Jun 23, 2000
POLYESTER NONABSORBABLE SURGICAL SUTURES URP
K001172 · GAT
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
NYLON, NONABSORBABLE SURGICAL SUTURES USP
K001173 · GAR
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
SILK, NONABSORBABLE, SURGICAL SUTURES, USP
K001184 · GAP
Cp Medical
General & Plastic Surgery · 73d
Cleared Jun 23, 2000
POLYPROPYLENE, NONABSORBABLE SURGICAL SUTURES USP
K001185 · GAW
Cp Medical
General & Plastic Surgery · 73d