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
105769–105792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 10, 1994
PLM SENSOR, MODEL PLM1
K940014 · BZQ
Pro-Tech, Inc.
Anesthesiology · 310d
Cleared Nov 10, 1994
R-GROUP INTERNATIONAL COILED LOW PRESSURE EXTENSION LINE
K940319 · FPA
R-Group Intl.
General Hospital · 290d
Cleared Nov 10, 1994
PCA MODULAR PRIMARY/REVISION PATELLA
K940713 · JWH
Howmedica Corp.
Orthopedic · 266d
Cleared Nov 10, 1994
CONNECTORS AND AIRWAY EXTENSIONS
K940889 · CAI
Cleveland Tubing, Inc.
Anesthesiology · 258d
Cleared Nov 10, 1994
CORRUGATED TUBING
K940890 · CAI
Cleveland Tubing, Inc.
Anesthesiology · 289d
Cleared Nov 10, 1994
COMPLETE CPR KIT
K941008 · CBP
Mtm Health Products , Ltd.
Anesthesiology · 254d
Cleared Nov 10, 1994
DUPONT ACA STAR
K941050 · JJQ
Dupont Medical Products
Chemistry · 248d
Cleared Nov 10, 1994
SE5 ARTHROSCOPY SYTEM
K941333 · HRX
Stryker Endoscopy
Orthopedic · 237d
Cleared Nov 10, 1994
SNORING SENSOR
K941759 · BZQ
Epm Development Systems Corp.
Anesthesiology · 245d
Cleared Nov 10, 1994
DEPUY CEMENTED HIP PROSTHESIS
K942370 · JDI
Depuy, Inc.
Orthopedic · 176d
Cleared Nov 10, 1994
BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM
K942451 · LDM
Bio-Rad
Chemistry · 171d
Cleared Nov 10, 1994
TRI BLOCK POLUMER GEL SHEETING
K942695 · MDA
Silipos, Inc.
General & Plastic Surgery · 156d
Cleared Nov 10, 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
K942797 · GKZ
Dako Corp.
Hematology · 148d
Cleared Nov 10, 1994
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)
K943148 · JLX
Diagnostic Systems Laboratories, Inc.
Chemistry · 133d
Cleared Nov 10, 1994
NON-BREATHING VALVE
K943761 · CBP
Rondex Products, Inc.
Anesthesiology · 100d
Cleared Nov 10, 1994
VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS
K943866 · LEG
Sigma Diagnostics, Inc.
Chemistry · 94d
Cleared Nov 10, 1994
POLYVIOLENE SURGICL SUTURE
K943949 · GAT
Look, Inc.
General & Plastic Surgery · 100d
Cleared Nov 10, 1994
FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE
K944063 · LGI
Sigma Diagnostics, Inc.
Chemistry · 83d
Cleared Nov 10, 1994
DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM
K944093 · JJE
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 80d
Cleared Nov 10, 1994
HYDRODERM GEL WOUND DRESSING
K944333 · MGQ
Wilshire Medical Products
General & Plastic Surgery · 65d
Cleared Nov 10, 1994
TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR
K944371 · LFW
Sigma Diagnostics, Inc.
Chemistry · 64d
Cleared Nov 10, 1994
KODI OPTICAL CO., LTD. SUNGLASSES
K944484 · HQY
Kodi Optical Co. , Ltd.
Ophthalmic · 58d
Cleared Nov 10, 1994
VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE
K944566 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 50d
Cleared Nov 10, 1994
SUNGLASSES
K945001 · HQY
Long Sheng Optical Co., Ltd.
Ophthalmic · 28d