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
79081–79104 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 07, 2001
MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION
K012287 · MRR
Roche Diagnostics Corp.
Chemistry · 18d
Cleared Aug 07, 2001
CT COLONOGRAPHY/NAVIGATOR2
K012313 · JAK
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Aug 06, 2001
ADD-ON CONDYLE
K002790 · NEI
Walter Lorenz Surgical, Inc.
Dental · 333d
Cleared Aug 06, 2001
CONDUCTIVE GEL FOR ULTRASOUND
K002832 · GYB
Skylark Device & Systems Co., Ltd.
Neurology · 329d
Cleared Aug 06, 2001
CROSS-CHECKS DUAL, MODEL CI 125
K010534 · JOJ
Steritec Products, Inc.
General Hospital · 164d
Cleared Aug 06, 2001
MUSCLE IMAGING SYSTEM (MIS)
K011416 · LNH
Millennium Magnetic Imaging, Inc.
Radiology · 90d
Cleared Aug 06, 2001
CHILLIT
K011666 · EAT
Heatshield, Inc.
Dental · 68d
Cleared Aug 06, 2001
FLEXICAST PRIME
K011706 · EJH
American Dent-All, Inc.
Dental · 63d
Cleared Aug 06, 2001
TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 3
K011751 · INI
Merits Health Products., Inc.
Physical Medicine · 61d
Cleared Aug 06, 2001
STERILE POWDER FREE SYNTHETIC VINYL PATIENT EXAM GLOVE
K012282 · LYZ
Cypress Medical Products, Ltd.
General Hospital · 17d
Cleared Aug 06, 2001
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER...
K981693 · LFD
Gebauer Co.
Dental · 1181d
Cleared Aug 06, 2001
DISPO ETCH
K984380 · KOJ
Kis Products
Dental · 972d
Cleared Aug 06, 2001
DISPODRILL
K993124 · KOJ
Kis Products
Dental · 686d
Cleared Aug 06, 2001
DISPOPROPHY
K993182 · KOJ
Kis Products
Dental · 683d
Cleared Aug 03, 2001
MICROSTIM 100I TENS DEVICE
K010295 · GZJ
Microstim, Inc.
Neurology · 184d
Cleared Aug 03, 2001
KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS
K010345 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 179d
Cleared Aug 03, 2001
GEO STRUCTURE
K010530 · MQP
Interpore Cross Intl.
Orthopedic · 161d
Cleared Aug 03, 2001
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
K011031 · MMW
Vysis
Immunology · 120d
Cleared Aug 03, 2001
ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM
K011102 · HWC
Aesculap, Inc.
Orthopedic · 114d
Cleared Aug 03, 2001
EBI OSTEOSTIM GRANULES-RESORBABLE BONE GRAFT SUBSTITUTE
K011386 · MQV
Ebi, L.P.
Orthopedic · 88d
Cleared Aug 03, 2001
PERSYST REVEAL
K011397 · OMB
Persyst Development Corp.
Neurology · 88d
Cleared Aug 03, 2001
THREADED CEMENT RESTRICTOR (CR) TITANIUM
K011443 · JDK
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 84d
Cleared Aug 03, 2001
IN SPACE 3D
K011447 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Aug 03, 2001
MP-3C POWER BASE CHAIR, MODEL MP3C
K011687 · ITI
Merits Health Products., Inc.
Physical Medicine · 64d