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
49297–49320 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 08, 2010
FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM
K100011 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 277d
Cleared Oct 08, 2010
JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC...
K100653 · EBI
Lang Dental Mfg. Co., Inc.
Dental · 214d
Cleared Oct 08, 2010
HT III SA FIXTURE SYSTEM
K101096 · DZE
Hiossen, Inc.
Dental · 171d
Cleared Oct 08, 2010
APEXNRG RIDER
K101177 · LQY
Medicnrg , Ltd.
Dental · 164d
Cleared Oct 08, 2010
LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE
K101331 · DQK
C.R. Bard Inc., Bard...
Cardiovascular · 150d
Cleared Oct 08, 2010
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE
K101594 · LZA
Better Care Plastic Technology Cp., Ltd.
General Hospital · 122d
Cleared Oct 08, 2010
UNITED U2 BIPOLAR IMPLANT
K101670 · KWY
United Orthopedic Corp.
Orthopedic · 116d
Cleared Oct 08, 2010
DUOLINK II
K101787 · EMA
Bisco, Inc.
Dental · 105d
Cleared Oct 08, 2010
AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017
K102059 · FET
Olympus Medical Systems Corporation
Gastroenterology & Urology · 78d
Cleared Oct 08, 2010
OSTENE CT, AOC CT, OSTEOTENE, CERETENE
K102071 · MTJ
Ceremed , Inc.
General & Plastic Surgery · 77d
Cleared Oct 08, 2010
BLUE SAIL INNOVATION
K102161 · LYZ
Shandong Blue Sail Innovation Co., Ltd.
General Hospital · 67d
Cleared Oct 08, 2010
IONOLUX PRO
K102450 · EBF
Voco GmbH
Dental · 42d
Cleared Oct 08, 2010
SECURMARK BIOPSY SITE MARKING SYSTEM
K102608 · NEU
Suros Surgical Systems, Inc. A...
General & Plastic Surgery · 28d
Cleared Oct 07, 2010
IMMULISA MPO ANTIBODY ELISA
K092599 · MOB
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Oct 07, 2010
IMMULISA PR3 ANTIBODY ELISA
K092600 · MOB
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Oct 07, 2010
IMMULISA ANCA SCREEN ELISA
K092601 · MOB
Immco Diagnostics, Inc.
Immunology · 409d
Cleared Oct 07, 2010
DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE...
K092973 · IKT
Bionen S.A.S.
Neurology · 377d
Cleared Oct 07, 2010
NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103
K100077 · DQA
Solaris Medical Technology, Inc.
Anesthesiology · 268d
Cleared Oct 07, 2010
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
K101166 · LLZ
Ge Healthcare
Radiology · 164d
Cleared Oct 07, 2010
MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE
K101280 · NLF
Midwest Reprocessing Center, LLC
Anesthesiology · 154d
Cleared Oct 07, 2010
OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM
K101939 · HSB
Merete Medical GmbH
Orthopedic · 87d
Cleared Oct 07, 2010
GIRAFFE2
K102133 · MVL
Kerr Corporation
Dental · 70d
Cleared Oct 07, 2010
EXCELLA II SPINAL SYSTEM MODEL EC2-00
K102248 · NKB
Innovasis, Inc.
Orthopedic · 59d
Cleared Oct 07, 2010
ELECSYS IGE CALCHECK 5
K102269 · JJX
Roche Diagnostics
Immunology · 59d