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
72553–72576 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 30, 2003
ACROSEAL ROOT CANAL OR APICAL SEALER
K023976 · KIF
Septodont S.A.S.
Dental · 64d
Cleared Jan 30, 2003
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
K024017 · NCW
Bayer Corp.
Immunology · 57d
Cleared Jan 29, 2003
CARDIMA ABLATION SYSTEM
K022008 · OCL
Cardima, Inc.
Cardiovascular · 224d
Cleared Jan 29, 2003
MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA
K022807 · GEX
Creative Technologies, Inc.
General & Plastic Surgery · 159d
Cleared Jan 29, 2003
SAS RSV TEST
K022845 · GQG
Sa Scientific, Inc.
Microbiology · 155d
Cleared Jan 29, 2003
1-CCD ENDOCAM 5520 SYSTEM
K023659 · FET
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 90d
Cleared Jan 29, 2003
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677 · LIB
Osmetech
Microbiology · 89d
Cleared Jan 29, 2003
AURORA MR-GUIDED INTERVENTIONAL SYSTEM
K023686 · LNH
Aurora Imaging Technology, Inc.
Radiology · 89d
Cleared Jan 29, 2003
BICON TRANSITIONAL IMPLANT (BTI) SYSTEM
K023705 · DZE
Bicon, Inc.
Dental · 86d
Cleared Jan 29, 2003
DEVEX MESH SYSTEM
K023835 · MQP
Depuyacromed
Orthopedic · 72d
Cleared Jan 29, 2003
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
K030049 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 23d
Cleared Jan 29, 2003
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
K030191 · IYN
Teratech Corp.
Radiology · 8d
Cleared Jan 29, 2003
APEX 90
K030206 · EJT
We Dong Myung Dental Industrial Co.,...
Dental · 8d
Cleared Jan 28, 2003
BIOSORB RESORBABLE VOID FILLER
K021963 · MQV
Sciences ET Bio Materiaux (Sbm)
Orthopedic · 228d
Cleared Jan 28, 2003
SW-180 SHORTWAVE THERAPY UNIT
K022846 · IMJ
Ito Co., Ltd.
Physical Medicine · 154d
Cleared Jan 28, 2003
LFRE INDIRECT LARYNGOSCOPE
K023004 · EOB
Astralite Corp.
Ear, Nose, Throat · 141d
Cleared Jan 28, 2003
SODEM HIGH SPEED SYSTEM (PNEUMATIC)
K023070 · ERL
Sodemsystems
Ear, Nose, Throat · 134d
Cleared Jan 28, 2003
GAS SAMPLING LINES
K023579 · CCK
Promedic, Inc.
Anesthesiology · 96d
Cleared Jan 28, 2003
UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100
K023764 · JJE
Beckman Coulter, Inc.
Chemistry · 77d
Cleared Jan 28, 2003
SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM
K023802 · HRS
Synthes (Usa)
Orthopedic · 75d
Cleared Jan 28, 2003
PRECIMED HIP SCREW SYSTEM
K023851 · KTT
Precimed, Inc.
Orthopedic · 70d
Cleared Jan 28, 2003
ALUMINA V40 FEMORAL HEADS
K023901 · LZO
Howmedica Osteonics Corp.
Orthopedic · 67d
Cleared Jan 28, 2003
TRILUMINA THERAPEUTIC LASER SYSTEM
K023935 · NHN
Texas Applied Biomedical Services
Physical Medicine · 63d
Cleared Jan 28, 2003
DISPOSBLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR
K024081 · LYZ
Safehealth Medical Supply Corp.
General Hospital · 48d