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
78649–78672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 31, 2001
AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY
K010865 · FLE
STERIS Corporation
General Hospital · 70d
Cleared May 31, 2001
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145
K010898 · LFL
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 66d
Cleared May 31, 2001
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN...
K010961 · LYY
Ansell Healthcare Products, Inc.
General Hospital · 62d
Cleared May 31, 2001
OSTEOBELL
K011104 · KNW
Biopsybell S.A.S.
Gastroenterology & Urology · 50d
Cleared May 31, 2001
VASOTRAC APM205A
K011152 · DXN
Medwave, Inc.
Cardiovascular · 45d
Cleared May 31, 2001
POWDER-FREE VINYL EXAM GLOVES
K011412 · LYZ
Heyuan Hongli Industries, Inc.
General Hospital · 23d
Cleared May 31, 2001
ACTIWARE-PLMS
K011430 · GWQ
Mini-Mitter Co., Inc.
Neurology · 22d
Cleared May 31, 2001
POWDERED SYNTHETIC (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K011474 · LYZ
Shijiazhuang Junfei Plastic Products...
General Hospital · 17d
Cleared May 30, 2001
SCAPHIX, STAPLE, FIXATION, BONE
K003033 · JDR
Avanta Orthopaedics, Inc.
Orthopedic · 244d
Cleared May 30, 2001
REBSTOCK YASARGIL ANEURYSM CLIP
K003500 · HCH
Rebstock - Instrumente GmbH
Neurology · 198d
Cleared May 30, 2001
SYNTHES RESORABLE MESHES AND SHEETS
K003788 · HRS
Synthes (Usa)
Orthopedic · 173d
Cleared May 30, 2001
CONVERGENCE CERVICAL SPINAL SYSTEM
K010639 · KWQ
Spinal Innovations, LLC
Orthopedic · 86d
Cleared May 30, 2001
ENSIL FABRIC
K010675 · MDA
Gottfried Medical, Inc.
General & Plastic Surgery · 85d
Cleared May 30, 2001
VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD,...
K010716 · FSY
Valmed Corp.
General & Plastic Surgery · 82d
Cleared May 30, 2001
BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS
K010773 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 77d
Cleared May 30, 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · HWC
Osteomed Corp.
Orthopedic · 76d
Cleared May 30, 2001
PERC-D SPINEWAND
K010811 · HRX
Arthrocare Corp.
Orthopedic · 72d
Cleared May 30, 2001
MARK 9000 PHASED ARRAY SHOULDER COIL
K010946 · MOS
Usa Instruments, Inc.
Radiology · 62d
Cleared May 30, 2001
INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000
K011002 · NAY
Intuitive Surgical, Inc.
General & Plastic Surgery · 57d
Cleared May 30, 2001
FORTAFLEX SURGICAL SLING
K011027 · FTM
Organogenesis, Inc.
General & Plastic Surgery · 55d
Cleared May 30, 2001
SUTURTEK FASTCLOSE FASCIA CLOSURE DEVICE
K011105 · GAL
Qrc Consulting
General & Plastic Surgery · 49d
Cleared May 30, 2001
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES)
K011111 · KPR
Modular X-Ray Devices
Radiology · 49d
Cleared May 30, 2001
EUB-6000 DIAGNOSTIC ULTRASOUND SCANNER SP-711 SONOPROBE SYSTEM
K011252 · IYO
Hitachi Medical Corp.
Radiology · 36d
Cleared May 30, 2001
PROGNOST ES, MODEL 0302 0000
K011290 · IZF
Xmar Corp.
Radiology · 33d