Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
61105–61128 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 20, 2006
D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT
K061101 · GNW
Diagnostic Hybrids, Inc.
Microbiology · 214d
Cleared Nov 20, 2006
CADI, VERSION 4
K062237 · LLZ
Synca Marketing, Inc.
Radiology · 110d
Cleared Nov 20, 2006
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
K062746 · DBF
Medicon Hellas S.A
Immunology · 67d
Cleared Nov 20, 2006
MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN...
K062938 · LON
Dade Behring, Inc.
Microbiology · 53d
Cleared Nov 20, 2006
INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80...
K063315 · MHX
Philips Medizin Systeme Boeblingen GmbH
Cardiovascular · 18d
Cleared Nov 17, 2006
RESPIRATOR N95 PARTICULATE RESPIRATOR, MODEL 1730
K061375 · MSH
Louis M. Gerson Co., Inc.
General Hospital · 184d
Cleared Nov 17, 2006
ASAHI PRECIOUS GUIDE CATHETER
K061601 · DQY
Asahi Intecc Co., Ltd.
Cardiovascular · 162d
Cleared Nov 17, 2006
ELECTROSURGICAL CUTTING AND COAGULATION DEVICE AND ACCESSORIES
K061829 · GEI
New Leaf Medical, Inc.
General & Plastic Surgery · 142d
Cleared Nov 17, 2006
NIO 5MP-M-21 (NIO 5MP MAMMO)
K062131 · LLZ
Barcoview
Radiology · 114d
Cleared Nov 17, 2006
ROCKWELL MEDICALTECHNOLOGIES, INC. CITRAPURE
K062399 · KPO
Rockwell Medical Technologies, Inc.
Gastroenterology & Urology · 93d
Cleared Nov 17, 2006
RETINAL FUNCTIONAL IMAGER (RFI)
K062416 · HKI
Optical Imaging , Ltd.
Ophthalmic · 92d
Cleared Nov 17, 2006
APERFIX FEMORAL IMPLANT WITH INSERTER
K062487 · HWC
Cayenne Medical, Inc.
Orthopedic · 84d
Cleared Nov 17, 2006
LAVA SOFTWARE
K062493 · NHA
3M Espe AG Dental Products
Dental · 84d
Cleared Nov 17, 2006
AESCULAP STERILCONTAINER SYSTEM
K062510 · FRG
Aesculap
General Hospital · 81d
Cleared Nov 17, 2006
TRU-MR LARYNGOSCOPE SET
K062523 · CCW
Truphatek International, Ltd.
Anesthesiology · 81d
Cleared Nov 17, 2006
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
K062851 · MQN
Osteomed LP
Dental · 53d
Cleared Nov 17, 2006
ENA HFO COMPOSITE SYSTEM
K062906 · EBF
Micerium S.P.A.
Dental · 51d
Cleared Nov 17, 2006
NITRILE POWDER FREE EXAMINATION GLOVES (GREEN)
K063046 · LZA
Hartalega Sdn Bhd
General Hospital · 44d
Cleared Nov 17, 2006
RII INFRARED EAR THERMOMETER, MODELS TH5XY SERIES
K063185 · FLL
Radiant Innovation, Inc.
General Hospital · 28d
Cleared Nov 17, 2006
INJEKT SYRINGE
K063280 · FMF
B.Braun Medical, Inc.
General Hospital · 17d
Cleared Nov 17, 2006
DEFINIUM 5000 X-RAY SYSTEM
K063283 · MQB
Sedecal., Sa.
Radiology · 18d
Cleared Nov 17, 2006
FLEX LOOP COIL SET 3T
K063373 · MOS
Siemens AG
Radiology · 9d
Cleared Nov 17, 2006
GO GO ELITE TRAVELLER PLUS 4 WHEEL SCOOTER, MODEL SC54
K063389 · INI
Pride Mobility Products Corp.
Physical Medicine · 15d
Cleared Nov 16, 2006
RAPIRUN H. PYLORI ANTIBODY DETECTION KIT
K052716 · LYR
Otsuka Pharmaceutical Co., Ltd.
Microbiology · 413d