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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
41209–41232 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 21, 2013
SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2
K122735 · GAT
Sorin Group USA, Inc.
General & Plastic Surgery · 257d
Cleared May 21, 2013
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK...
K123322 · CDN
Alfa Wassermann Diagnostics...
Chemistry · 207d
Cleared May 21, 2013
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
K123726 · JGS
Roche Diagnostics
Chemistry · 168d
Cleared May 21, 2013
REMSTAR SE
K130077 · BZD
Respironics, Inc.
Anesthesiology · 127d
Cleared May 21, 2013
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
K130189 · NTI
Luminex Molecular Diagnostics, Inc.
Chemistry · 116d
Cleared May 21, 2013
HEALIX ADVANCE KNOTLESS PEEK ANCHOR (4.75MM)(5.5MM)
K130539 · MBI
Depuy Mitek, A Johnson & Johnson Company
Orthopedic · 81d
Cleared May 21, 2013
ALLURA XPER FD OR TABLE SERIES
K130842 · IZI
Philips Medical Systems Nederland B.V.
Radiology · 55d
Cleared May 21, 2013
ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM
K131093 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 33d
Cleared May 21, 2013
SOLANAS POSTERIOR STABILIZATION SYSTEM
K131119 · NKB
Alphatec Spine, Inc.
Orthopedic · 29d
Cleared May 20, 2013
ROYAL-DENT EUREKA DENTAL IMPLANT SYSTEM
K122804 · DZE
Intai Technology Corp.
Dental · 249d
Cleared May 20, 2013
ACME SURGICAL FACE MASK WITH EAR-LOOP MODEL YN-501 AB/W/G/P
K123115 · FXX
Acme Filter Mask, Inc.
General Hospital · 229d
Cleared May 20, 2013
NORDIC TUMOREX
K123306 · LLZ
Nordicneurolab
Radiology · 208d
Cleared May 20, 2013
MIROCAM CAPSULE ENDOSCOPE SYSTEM
K123428 · NEZ
Intromedic Co., Ltd.
Gastroenterology & Urology · 194d
Cleared May 20, 2013
SYNTHES SYNFLATE VERTEVRAL BALLOON SYSTEM
K130146 · NDN
Synthes (Usa), LLC
Orthopedic · 118d
Cleared May 20, 2013
3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL
K130457 · MOS
Resonance Innovations, LLC
Radiology · 87d
Cleared May 20, 2013
AIGIS RX R PM/ AIGIS RX R ICD
K130943 · FTL
Tyrx, Inc.
General & Plastic Surgery · 46d
Cleared May 17, 2013
DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03)
K120671 · FLL
Cotronic Technology Limited
General Hospital · 438d
Cleared May 17, 2013
HUMAN IGG CSF KIT
K120749 · CFN
The Binding Site Group , Ltd.
Immunology · 431d
Cleared May 17, 2013
HUMAN IGM CSF KIT
K120750 · CFN
The Binding Site Group , Ltd.
Immunology · 431d
Cleared May 17, 2013
AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE
K121976 · MPN
Aesculap, Inc.
General & Plastic Surgery · 316d
Cleared May 17, 2013
SCOPEVALET DISPOSABLE BIOPSY VALVE
K122417 · OCX
The Ruhof Corp.
Gastroenterology & Urology · 282d
Cleared May 17, 2013
TRYOUT-VPS HOLDING PASTE
K122974 · EMA
Crown Delta Corp.
Dental · 233d
Cleared May 17, 2013
NEODENT IMPLANT SYSTEM
K123022 · DZE
Jjgc Industria E Comercio DE...
Dental · 231d
Cleared May 17, 2013
MAGNETOM SKYRA
K123510 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 185d