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
77569–77592 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 2001
BANDVIEW SYSTEM
K012103 · LNJ
Applied Spectral Imaging , Ltd.
Pathology · 71d
Cleared Sep 14, 2001
ACTICLOT PROTEIN S, MODEL 843L
K012386 · GGP
American Diagnostica, Inc.
Hematology · 49d
Cleared Sep 14, 2001
BIOTEQUE SCALP VEIN SET
K012526 · FPA
Bioteque Corp.
General Hospital · 39d
Cleared Sep 14, 2001
CARIES DETECTOR
K012733 · LFC
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CLEARFIL NEW BOND
K012734 · KLE
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CLEARFIL DC CEMENT
K012735 · EMA
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CHROMA ZONE COLOR STAIN
K012737 · EBF
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
CLEARFIL AP-X
K012740 · EBF
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
TEETHMATE F-1
K012742 · EBC
Kuraray Medical, Inc.
Dental · 31d
Cleared Sep 14, 2001
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
K012743 · DRY
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Sep 14, 2001
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747 · DPT
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Sep 14, 2001
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · MLD
Datex-Ohmeda
Cardiovascular · 22d
Cleared Sep 14, 2001
SIMPLICITY SOFT QD MICRO INFUSION SET
K012845 · FPA
Sterling Medivations, Inc.
General Hospital · 22d
Cleared Sep 13, 2001
COLORMATE TLC BILITEST SYSTEM
K001687 · MQM
Chromatics Color Sciences Intl., Inc.
Chemistry · 469d
Cleared Sep 13, 2001
EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K011240 · NBW
Medline Industries, Inc.
Chemistry · 143d
Cleared Sep 13, 2001
OTO-CEM
K011338 · NEA
Ototech, Inc.
Ear, Nose, Throat · 134d
Cleared Sep 13, 2001
MX8000 IDT CT SYSTEM
K012009 · JAK
Marconi Medical Systems, Inc.
Radiology · 78d
Cleared Sep 13, 2001
AQUARIUSNET SERVER
K012086 · LLZ
Terarecon,Inc.
Radiology · 72d
Cleared Sep 13, 2001
ESTENIA
K012707 · EBF
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
CLEARFIL REPAIR
K012729 · KLE
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
CLEARFIL PORCELAIN BOND ACTIVATOR
K012730 · KLE
Kuraray Medical, Inc.
Dental · 30d
Cleared Sep 13, 2001
SYNERGY TI INTEGRAL OPEN SCREWS MODELS # 6193, 6194, 6195,6196, 6173, 6174,...
K012871 · KWP
Interpore Cross Intl.
Orthopedic · 17d
Cleared Sep 12, 2001
VECTORVISION HIP
K010602 · HAW
Brainlab AG
Neurology · 196d
Cleared Sep 12, 2001
SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM
K011857 · HSB
Synthes (Usa)
Orthopedic · 90d