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
87073–87096 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 22, 1998
RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D
K983653 · DRF
Cardiac Pathways Corp.
Cardiovascular · 64d
Cleared Dec 22, 1998
BENZ G-5X (HIOXIFILCON A) SOFT DAILY WEAR CONTACT LENS
K983773 · LPL
Benz Research and Development Corp.
Ophthalmic · 57d
Cleared Dec 22, 1998
DEPUY ACE TIMAX META PLATE
K983853 · HRS
Depuy Ace Medical Co.
Orthopedic · 53d
Cleared Dec 22, 1998
THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
K983899 · KWQ
United States Surgical, A Division of...
Orthopedic · 49d
Cleared Dec 22, 1998
ROGOZINSKI SPINAL ROD SYSTEM
K983904 · KWP
United States Surgical, A Division of...
Orthopedic · 49d
Cleared Dec 22, 1998
REAADS MONOCLONAL FREE PROTEIN S ANTIGEN TEST KIT
K983914 · GGP
Corgenix, Inc.
Hematology · 48d
Cleared Dec 22, 1998
CO2 LASER COUPLER
K983965 · GEX
L.A.S.E.R., Inc.
General & Plastic Surgery · 46d
Cleared Dec 22, 1998
ADVENT
K984112 · EBF
Bisco, Inc.
Dental · 35d
Cleared Dec 22, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM
K984173 · MID
Zeus Scientific, Inc.
Immunology · 32d
Cleared Dec 22, 1998
ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05
K984319 · JJX
Bio-Rad
Chemistry · 19d
Cleared Dec 22, 1998
ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05
K984327 · JJX
Bio-Rad
Chemistry · 19d
Cleared Dec 22, 1998
LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206
K984462 · LLL
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211
K984464 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209
K984470 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205
K984473 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212
K984475 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207
K984476 · LKO
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210
K984478 · LKJ
Bio-Rad
Immunology · 6d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479 · LKP
Bio-Rad
Immunology · 6d
Cleared Dec 21, 1998
INSIGHT DIAGNOSTIC IMAGING WORKSTATION
K982535 · LLZ
Neo Imagery Technologies, Inc.
Radiology · 154d
Cleared Dec 21, 1998
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
K982901 · LYY
Vitalcare Group, Inc.
General Hospital · 126d
Cleared Dec 21, 1998
MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE
K983342 · LHN
Philips Medical Systems (Cleveland),...
Radiology · 89d
Cleared Dec 21, 1998
MODEL MS-1 HANDPIECE
K983413 · EKX
Parkell, Inc.
Dental · 84d
Cleared Dec 21, 1998
SYNTHES 1.3 MM SELF-DRILLING SCREW
K983485 · DZL
Synthes (Usa)
Dental · 77d