FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
85153–85176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 1999
STECO-TITANMAGNETICS
K990979 · EGG
Steco-System-Technik GmbH & Cokg
Dental · 164d
Cleared Sep 03, 1999
PRISMATHERM II, ASTOLINE
K991159 · BSB
Stihler Electronic GmbH
Hematology · 149d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM
K991180 · LSR
Zeus Scientific, Inc.
Microbiology · 148d
Cleared Sep 03, 1999
BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM
K991185 · LSR
Zeus Scientific, Inc.
Microbiology · 148d
Cleared Sep 03, 1999
MUMPS IGG ELISA TEST SYSTEM
K991274 · LJY
Columbia Bioscience, Inc.
Microbiology · 143d
Cleared Sep 03, 1999
LIFEPAK 12 BIPHASIC
K991910 · MKJ
Physio-Control Corp.
Cardiovascular · 88d
Cleared Sep 03, 1999
MODULAR RADIAL HEAD
K991915 · KWI
Wrightmedicaltechnologyinc
Orthopedic · 88d
Cleared Sep 03, 1999
ULTRA-KLEEN POWDER FOR DENTAL UNIT WATER LINES, MODELS 513P, 505L
K991946 · EIA
Sterilex Corp.
Dental · 86d
Cleared Sep 03, 1999
THE NOMOS CHANE II
K991966 · IYE
Nomos Corp.
Radiology · 85d
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