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
74329–74352 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 06, 2002
F 900
K022054 · HKY
C.S.O. S.R.L.
Ophthalmic · 43d
Cleared Aug 06, 2002
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K022065 · JEC
Sintea Biotech, Inc.
Orthopedic · 42d
Cleared Aug 06, 2002
ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
K022209 · FPA
Alaris Medical Systems, Inc.
General Hospital · 29d
Cleared Aug 06, 2002
MOBILE MILLENNIUM MG SYSTEM
K022240 · KPS
Ge Medical Systems, Inc.
Radiology · 26d
Cleared Aug 06, 2002
STRYKER L3 HYDROLERT
K022248 · FLN
Stryker Endoscopy
General Hospital · 25d
Cleared Aug 06, 2002
SAFE MAXI VENOUS/CARDIOTOMY RESERVIOR, MODEL 016045
K022281 · DTN
Polystan A/S
Cardiovascular · 22d
Cleared Aug 06, 2002
BLACKSTONE SPINAL FIXATION SYSTEM SPACER
K022399 · KWQ
Blackstone Medical, Inc.
Orthopedic · 14d
Cleared Aug 06, 2002
SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K022400 · IYN
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Aug 06, 2002
QUANTITATIVE BLOOD POOL SPECT (QBS)
K022428 · LLZ
Adac Laboratories
Radiology · 12d
Cleared Aug 05, 2002
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
K001755 · FIP
Mpw Industrial Water Services, Inc.
Gastroenterology & Urology · 787d
Cleared Aug 05, 2002
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
K013704 · KLA
Mediplus , Ltd.
Gastroenterology & Urology · 270d
Cleared Aug 05, 2002
ELECSYS ANTI-TG TEST SYSTEM
K020672 · JZO
Roche Diagnostics Corp.
Immunology · 157d
Cleared Aug 05, 2002
MEDPOR PLUS ORBITAL VOLUME REPLACEMENT IMPANT
K021357 · HPZ
Porex Surgical, Inc.
Ophthalmic · 98d
Cleared Aug 05, 2002
POLY STAT HCG DIPSTICK TEST
K021386 · JHI
Alidex, Inc.
Chemistry · 95d
Cleared Aug 05, 2002
TOP GLOVE POWDERFREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIMS...
K021855 · LYY
Top Glove Sdn. Bhd.
General Hospital · 60d
Cleared Aug 05, 2002
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 11d
Cleared Aug 02, 2002
POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM
K012105 · KCT
Symmetry Medical, Inc.
General Hospital · 393d
Cleared Aug 02, 2002
BABY TEETHER, MODEL 20104
K014023 · KKO
Angelina Trading, Inc.
Dental · 239d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON...
K020120 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 200d
Cleared Aug 02, 2002
CRC-15BT
K020150 · KPT
Capintec, Inc.
Radiology · 198d
Cleared Aug 02, 2002
BONESOURCE HAC
K021440 · GXP
Stryker Instruments
General & Plastic Surgery · 88d
Cleared Aug 02, 2002
RAPIDO GUIDING CATHETER, 6F MODEL# 6776
K021455 · DQY
Guidant Corp.
Cardiovascular · 88d
Cleared Aug 02, 2002
C.T.M. POWER CHAIR, MODEL HS-2800
K021617 · ITI
C.T.M. Homecare Product, Inc.
Physical Medicine · 78d
Cleared Aug 02, 2002
DISETRONIC D-TRON INSULIN INFUSION PUMP
K021725 · LZG
Disetronic Medical Systems AG
General Hospital · 70d