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
84649–84672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 1999
CAPIOX SX10 HARDSHELL RESEVOIR
K991973 · DTN
Terumo Medical Corp.
Cardiovascular · 84d
Cleared Sep 03, 1999
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
K991979 · FPA
Medtronic Minimed
General Hospital · 81d
Cleared Sep 03, 1999
GILTECH PLUS TRANSPARENT DRESSING
K992005 · MGP
Giltech Plus, Inc.
General & Plastic Surgery · 80d
Cleared Sep 03, 1999
GRAND CERAM
K992023 · EIH
Noritake Co., Inc.
Dental · 79d
Cleared Sep 03, 1999
OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
K992063 · HSB
Howmedica Osteonics Corp.
Orthopedic · 77d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS (OFLOXACIN)
K992077 · JTN
Pasco Laboratories, Inc.
Microbiology · 74d
Cleared Sep 03, 1999
BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
K992088 · GAM
Genzyme Surgical Product (Genzyme...
General & Plastic Surgery · 74d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS (CEFEPIME)
K992108 · JWY
Pasco Laboratories, Inc.
Microbiology · 73d
Cleared Sep 03, 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 400C
K992130 · KQG
Pacific Hemostasis
Hematology · 72d
Cleared Sep 03, 1999
UROLOGICAL CATHETER
K992137 · GBM
Apogee, Inc.
Gastroenterology & Urology · 71d
Cleared Sep 03, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN...
K992166 · LGC
Zeus Scientific, Inc.
Microbiology · 70d
Cleared Sep 03, 1999
ENDO-ESOPHAGEAL MR COIL
K992193 · MOS
Surgi-Vision, Inc.
Radiology · 66d
Cleared Sep 03, 1999
QCT BONE MINERAL ANALYSIS SOFTWARE
K992246 · KGI
Image Analysis, Inc.
Radiology · 59d
Cleared Sep 03, 1999
LORAD 1-650 (INTERNATIONAL 650)
K992280 · IZH
Lorad Corp.
Radiology · 58d
Cleared Sep 03, 1999
PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN
K992297 · JTN
Pasco Laboratories, Inc.
Microbiology · 58d
Cleared Sep 03, 1999
BACTALERT FA
K992400 · MDB
Organon Teknika Corp.
Microbiology · 46d
Cleared Sep 03, 1999
BACT/ALERT PF
K992401 · MDB
Organon Teknika Corp.
Microbiology · 46d
Cleared Sep 03, 1999
URINE CHEMISTRY CONTROL, LEVEL 1
K992576 · JJW
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Sep 03, 1999
URINE CHEMISTRY CONTROL, LEVEL 2
K992578 · JJW
Consolidated Technologies, Inc.
Chemistry · 32d
Cleared Sep 03, 1999
O2N DEMAND-II, VICTOR MODEL OCPR-II
K992659 · NFB
Thermadyne Holings Corp.
Anesthesiology · 25d
Cleared Sep 03, 1999
EAGLE OPTION FOR THE QDR BONE DENSITOMETER, MODELS QDR4500, QDR2000, QDR1500,...
K992677 · KGI
Hologic, Inc.
Radiology · 24d
Cleared Sep 03, 1999
CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM
K992753 · MUJ
Varian Assoc., Inc.
Radiology · 18d
Cleared Sep 03, 1999
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
K992896 · EGY
Dental X-Ray Support Systems, Inc.
Radiology · 7d
Cleared Sep 02, 1999
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL...
K990867 · FGE
Advanced Cardiovascular Systems, Inc.
Gastroenterology & Urology · 170d