FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
85777–85800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 17, 1999
PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER AND ACCESSORIES
K991030 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 49d
Cleared May 17, 1999
IONOSIT BOND
K991172 · EMA
Dmg Chemisch Pharmazeutische Fabrik GmbH
Dental · 40d
Cleared May 17, 1999
OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT
K991461 · JWH
Howmedica Osteonics Corp.
Orthopedic · 20d
Cleared May 17, 1999
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K991627 · LBI
Respironics, Inc.
General Hospital · 6d
Cleared May 14, 1999
THE IMMUNO 1 CA 125 II ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO...
K983715 · LTK
Bayer Corp.
Immunology · 205d
Cleared May 14, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CA 125 II CALIBRATORS, VITROS...
K983875 · LTK
Ortho-Clinical Diagnostics, Inc.
Immunology · 193d
Cleared May 14, 1999
KERATOME SYSTEM, MODEL K3000
K984537 · HMY
Insight Technologies Instruments, LLC
Ophthalmic · 144d
Cleared May 14, 1999
OPTICAL FORCEPS
K990561 · JEK
Pilling Weck Surgical
Ear, Nose, Throat · 81d
Cleared May 14, 1999
TAS ANALYZER, MODEL 1009
K990566 · JPA
Cardiovascular Diagnostics, Inc.
Hematology · 81d
Cleared May 14, 1999
SCRAMBLED ENDOOTO LASER PROBE, STRAIGHT TIP, MODEL 59.02, SCRAMBLED ENDOOTO...
K990568 · GEX
Synergetics, Inc.
General & Plastic Surgery · 80d
Cleared May 14, 1999
EXCELART
K990620 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared May 14, 1999
CONSEAL F
K990650 · EBC
Southern Dental Industries, Inc.
Dental · 74d
Cleared May 14, 1999
FLEXNEEDLE PLUS
K990693 · FPA
Act Medical, Inc.
General Hospital · 72d
Cleared May 14, 1999
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210,...
K991048 · DHB
Pharmacia & Upjohn Co.
Immunology · 45d
Cleared May 14, 1999
K-ASSAY CRP
K991224 · DCK
Kamiya Biomedical Co.
Immunology · 32d
Cleared May 14, 1999
BONE MULCH SCREW SYSTEM
K991298 · HWC
Biomet, Inc.
Orthopedic · 29d
Cleared May 14, 1999
PLATYPUS AV FISTULA NEEDLE PROTECTOR (AVFNP)
K991404 · FMI
Itl Corporation Pty, Ltd.
General Hospital · 22d
Cleared May 14, 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459 · LJN
DiaSorin, Inc.
Microbiology · 18d
Cleared May 14, 1999
FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT...
K991550 · LPL
Wesley Jessen Corp.
Ophthalmic · 10d
Cleared May 13, 1999
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · KXK
Uromed Corp.
Radiology · 323d
Cleared May 13, 1999
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
K983575 · DXN
Datascope Corp.
Cardiovascular · 212d
Cleared May 13, 1999
LORENZ IMF SCREW
K983728 · DZL
Walter Lorenz Surgical, Inc.
Dental · 203d
Cleared May 13, 1999
ITI DENTAL IMPLANT SYSTEM
K984104 · DZE
Straumann USA
Dental · 177d
Cleared May 13, 1999
PULSEMASTER DENTAL LASER SYSTEM
K984486 · GEX
American Dental Technologies, Inc.
General & Plastic Surgery · 147d