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
113809–113832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 08, 1993
RMHS MONOLITHIC FEMORAL COMPONENT
K923275 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 276d
Cleared Apr 08, 1993
WRAPPEL T
K923408 · FRG
Standard Textile Co., Inc.
General Hospital · 272d
Cleared Apr 08, 1993
TISMESH SYSTEM
K923419 · JEY
Ti-Mesh, Inc.
Dental · 269d
Cleared Apr 08, 1993
URODYNAMICS TUBING KITS #5161, #5150, #7170
K923995 · FAP
Advanced Medical Products, Inc.
Gastroenterology & Urology · 241d
Cleared Apr 08, 1993
GLENROE ORTHO SEPS
K924139 · ECI
Glenroe Technologies
Dental · 233d
Cleared Apr 08, 1993
ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (CTR)
K924144 · HRX
Davol, Inc.
Orthopedic · 233d
Cleared Apr 08, 1993
ARTHRODYN 45 DEGREE X-RAY TABLE
K924326 · IXR
Arthrodyn, Inc.
Radiology · 224d
Cleared Apr 08, 1993
SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER
K924661 · KRA
Baxter Healthcare Corp
Cardiovascular · 205d
Cleared Apr 08, 1993
VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE
K925176 · GBX
Boston Scientific Corp
General & Plastic Surgery · 176d
Cleared Apr 08, 1993
MATRIX CR 2050, PMI 3000
K925289 · LMC
Heraeus Kulzer, Inc.
Radiology · 169d
Cleared Apr 08, 1993
DANEK TISSUE RESECTING SYSTEM
K925577 · HRX
Sofamor Danek Mfg., Inc.
Orthopedic · 156d
Cleared Apr 08, 1993
MULTI-TRAUMA DRESSING
K925590 · NAB
Gam Industries, Inc.
General & Plastic Surgery · 154d
Cleared Apr 08, 1993
OPUS SEROLOGY CONTROLS
K925703 · MJX
Pb Diagnostics, Inc.
Microbiology · 147d
Cleared Apr 08, 1993
NEAL WRIST CONES
K925924 · FMQ
Neal & Assoc., Inc.
General Hospital · 136d
Cleared Apr 08, 1993
MPM WET DRESSING (SALINE)
K926044 · KMF
Mpm Medical., Inc.
General & Plastic Surgery · 128d
Cleared Apr 08, 1993
SCIMED(R) 0.038 CONTROLWIRE(TM) PERIPHER GUIDE WIR
K926457 · DQX
Scimed Life Systems, Inc.
Cardiovascular · 105d
Cleared Apr 08, 1993
ARGION DENTAL CEMENT
K926492 · EMA
Voco GmbH
Dental · 100d
Cleared Apr 08, 1993
HEMOCARD HEMOGLOBIN E
K930070 · CKA
Isolab, Inc.
Hematology · 92d
Cleared Apr 08, 1993
CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER
K930455 · EMA
Voco GmbH
Dental · 71d
Cleared Apr 08, 1993
THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT
K930777 · JNL
Nichols Institute
Immunology · 51d
Cleared Apr 08, 1993
CONNECTORS AND AIRWAY EXTENSIONS
K931036 · BZA
Life Shield Healthcare Products, Inc.
Anesthesiology · 38d
Cleared Apr 08, 1993
CONNECTORS AND AIRWAY EXTENSIONS
K931038 · BZA
Med-Plastics Intl., Inc.
Anesthesiology · 38d
Cleared Apr 07, 1993
STRAIGHT-LINES I.V. ORGANIZER
K920965 · FRA
Taylor Bio-Medical, Inc.
General Hospital · 401d
Cleared Apr 07, 1993
COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED
K921740 · IYE
Medical Instrumentation & Diagnostics...
Radiology · 359d