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
72241–72264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 05, 2003
SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATING
K024065 · DTN
Gish Biomedical, Inc.
Cardiovascular · 86d
Cleared Mar 05, 2003
IVD CRYPTO/GIARDIA DFA
K024113 · MHI
Ivd Research, Inc.
Microbiology · 82d
Cleared Mar 05, 2003
SMEARCLEAR
K024198 · KJJ
Sybron Dental Specialties, Inc.
Dental · 75d
Cleared Mar 05, 2003
NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED)
K030075 · LZA
Best Manufacturing...
General Hospital · 56d
Cleared Mar 05, 2003
MODIFICATION TO CAPIOX SX10 HARDSHELL RESERVOIR
K030449 · DTN
Terumo Corp.
Cardiovascular · 22d
Cleared Mar 05, 2003
3.0T TORSO PHASED ARRAY COIL
K030495 · MOS
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Mar 04, 2003
ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS
K021878 · LPH
Eska America Corp.
Orthopedic · 270d
Cleared Mar 04, 2003
HOME CARE VARIOUS MODELS OF SELF-ADHESIVE ELECTRODES
K022917 · GXY
Home Care Technology Co., Ltd.
Neurology · 182d
Cleared Mar 04, 2003
SELF SEAL STERILIZATION POUCH
K023025 · FRG
Granton Medical , Ltd.
General Hospital · 174d
Cleared Mar 04, 2003
NUVASIVE MASH
K023319 · MQP
Nuvasive, Inc.
Orthopedic · 151d
Cleared Mar 04, 2003
ORIA CERVICAL PLATES
K023377 · KWQ
Ortho Tec, LLC
Orthopedic · 147d
Cleared Mar 04, 2003
STAIRFRIEND CURVED STAIRWAY CHAIRLIFT
K023852 · ILK
Services Industriels Savaria, Inc.
Physical Medicine · 105d
Cleared Mar 04, 2003
REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS
K024015 · NLM
Alliance Medical Corp.
Gastroenterology & Urology · 90d
Cleared Mar 04, 2003
VIDAR BONE TRACK SYSTEM SOFTWARE
K024171 · JAK
Vidar Systems Corp.
Radiology · 76d
Cleared Mar 04, 2003
MIIG II BONE GRAFT SUBSTITUTE
K024336 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Mar 04, 2003
THE MULTILIFT
K024346 · ING
Services Industriels Savaria, Inc.
Physical Medicine · 67d
Cleared Mar 04, 2003
ANESTHESIA MONITOR
K030105 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 50d
Cleared Mar 04, 2003
IGLIDE MANUAL ASSIST WHEELCHAIR
K030250 · ITI
Independence Technology, LLC
Physical Medicine · 39d
Cleared Mar 04, 2003
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
K030265 · JDI
Zimmer, Inc.
Orthopedic · 36d
Cleared Mar 04, 2003
MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS
K030344 · KWS
Smith & Nephew, Inc.
Orthopedic · 29d
Cleared Mar 04, 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT,...
K030408 · GKZ
Beckman Coulter, Inc.
Hematology · 25d
Cleared Mar 04, 2003
SKINTACT ECG TAB ELECTRODE
K030509 · DRX
Leonhard Lang GmbH
Cardiovascular · 13d
Cleared Mar 03, 2003
MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005
K021537 · GXY
Vermont Medical, Inc.
Neurology · 297d
Cleared Mar 03, 2003
BABYCARE
K023082 · HEP
Bionet Company, Ltd.
Radiology · 167d