FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
79153–79176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 01, 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared Jun 01, 2001
SENTINEL ENTERAL FEEDING PUMP, LH2001 ENTERAL FEEDING PUMP
K011587 · LZH
Entracon Corp.
General Hospital · 9d
Cleared May 31, 2001
ESU HANDSWITCHING PENCIL
K001442 · GEI
Surgex, Inc.
General & Plastic Surgery · 388d
Cleared May 31, 2001
CADHEALTH SYSTEM, MODEL CHP-001
K002514 · DRG
Caduceus Health Care , Ltd.
Cardiovascular · 289d
Cleared May 31, 2001
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
K002847 · DYB
Maxxim Medical
Cardiovascular · 260d
Cleared May 31, 2001
NAT - NUCLEIC ACID TRANSPORT
K003761 · LIO
Medical Packaging Corp.
Microbiology · 176d
Cleared May 31, 2001
LAPAROSCOPIC HAND PORT
K003871 · GCJ
Applied Medical Resources Corp.
General & Plastic Surgery · 167d
Cleared May 31, 2001
BUTTERFLY PLATE FUNCTION SYSTEM
K010632 · KWP
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 90d
Cleared May 31, 2001
VERSYO.COM
K010800 · EBI
Heraeus Kulzer, Inc.
Dental · 76d
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