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
68473–68496 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 2004
TEMP F
K040343 · EMA
Novocol, Inc.
Dental · 173d
Cleared Aug 03, 2004
NEUROGUIDE ANALYSIS SYSTEM
K041263 · OLU
Applied Neuroscience, Inc.
Neurology · 84d
Cleared Aug 03, 2004
BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE
K041384 · LON
Becton, Dickinson & CO
Microbiology · 70d
Cleared Aug 03, 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 56d
Cleared Aug 03, 2004
VERSAWAVE DENTAL ER:YAG LASER SYSTEM
K041710 · GEX
Hoya Conbio
General & Plastic Surgery · 41d
Cleared Aug 03, 2004
PASCO MIC AND MIC/ID PANELS
K041776 · JWY
Pasco Laboratories, Inc.
Microbiology · 33d
Cleared Aug 03, 2004
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K041796 · FGE
Cordis Corporation
Gastroenterology & Urology · 32d
Cleared Aug 03, 2004
PASSING NEEDLE WITH ETHIBOND, PANACRYL OR ORTHOCORD SUTURE
K041806 · GAM
Depuy Mitek, A Johnson & Johnson Company
General & Plastic Surgery · 28d
Cleared Aug 03, 2004
BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND...
K041970 · MEG
Biotop Technology Co., Ltd.
General Hospital · 12d
Cleared Aug 03, 2004
NIGHTFORM
K041996 · FRP
Plastic Surgery Solutions, LLC
General Hospital · 8d
Cleared Aug 02, 2004
OLYMPUS STERILIZATION TRAYS
K033222 · KCT
Olympus Winter & Ibe GmbH
General Hospital · 304d
Cleared Aug 02, 2004
ALLOMATRIX PUTTY
K041168 · MQV
Wrightmedicaltechnologyinc
Orthopedic · 90d
Cleared Aug 02, 2004
CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996
K041173 · MVM
Sweden Diagnostics (Germany) GmbH
Immunology · 89d
Cleared Aug 02, 2004
VARELISA GLIADIN IGG ANTIBODIES
K041357 · MST
Sweden Diagnostics (Germany) GmbH
Immunology · 74d
Cleared Aug 02, 2004
BIO 60
K041378 · EJT
Kodent, Inc.
Dental · 70d
Cleared Aug 02, 2004
MARPAC MESSENGER MODEL #501
K041485 · JOH
Marpac, Inc.
Anesthesiology · 59d
Cleared Jul 30, 2004
THERA-CREAM, MODEL TCT004
K032239 · GYB
Prizm Medical, Inc.
Neurology · 375d
Cleared Jul 30, 2004
SOFLEX SOFT K (XYLOFILCON A) SOFT (HYDROPHILIC) KERATOCONUS CONTACT LENS FOR...
K033655 · LPL
Soflex Contact Lens Industries , Ltd.
Ophthalmic · 252d
Cleared Jul 30, 2004
M'ATH STD
K040686 · LLZ
Intelligence IN Medical Technologies
Radiology · 136d
Cleared Jul 30, 2004
MODIFICATION TO SMALL BONE FIXATION SYSTEM
K041157 · HTY
Hand Innovations, Inc.
Orthopedic · 88d
Cleared Jul 30, 2004
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
K041352 · KRO
Biomet, Inc.
Orthopedic · 71d
Cleared Jul 30, 2004
HUMERAL STAPLE
K041355 · HTY
Smith & Nephew, Inc.
Orthopedic · 71d
Cleared Jul 30, 2004
ANTERIOR COMPACT SYSTEM
K041469 · KWQ
X-Spine Systems
Orthopedic · 58d
Cleared Jul 30, 2004
UNDECIDED
K041484 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 56d