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

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176,076 results
53905–53928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 02, 2009
COOK MREYE EMBOLIZATION COILS
K090624 · KRD
Cook, Inc.
Cardiovascular · 24d
Cleared Apr 02, 2009
ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND...
K090713 · OTP
American Medical Systems, Inc.
Obstetrics & Gynecology · 15d
Cleared Apr 01, 2009
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
K081527 · GQL
Millipore Corporation
Microbiology · 303d
Cleared Apr 01, 2009
ALCO TUBE PLUS
K082080 · DJZ
Alcotest Quebec
Toxicology · 252d
Cleared Apr 01, 2009
SOPRO 184 CAMERA
K082796 · GCJ
Sopro
General & Plastic Surgery · 190d
Cleared Apr 01, 2009
NAVIGATOR APPLICATIONS SUITE
K083098 · BSZ
GE Healthcare Finland Oy
Anesthesiology · 166d
Cleared Apr 01, 2009
SPINE & TRAUMA ICT
K083310 · OLO
Brainlab AG
Orthopedic · 142d
Cleared Apr 01, 2009
XIA 3 SPINAL SYSTEM
K083393 · NKB
Stryker Spine
Orthopedic · 135d
Cleared Apr 01, 2009
SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY
K083524 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 124d
Cleared Apr 01, 2009
SURGYBONE
K083569 · DZI
Silfradent S.R.L.
Dental · 119d
Cleared Apr 01, 2009
PK-141 PATIENT CABLE
K083674 · DTC
Biotronik, Inc.
Cardiovascular · 111d
Cleared Apr 01, 2009
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C
K083820 · DSH
Vasomedical, Inc.
Cardiovascular · 100d
Cleared Apr 01, 2009
SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM
K090047 · HRS
Synthes (Usa)
Orthopedic · 84d
Cleared Apr 01, 2009
STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
K090163 · DRB
St Jude Medical
Cardiovascular · 69d
Cleared Apr 01, 2009
REPROCESSED ELECTROPHYSIOLOGY CATHETERS
K090323 · NLH
Ascent Healthcare Solutions
Cardiovascular · 51d
Cleared Apr 01, 2009
SPINESMITH CYNCH SPINAL SYSTEM
K090376 · MAX
Spine Smith Partners L.P.
Orthopedic · 43d
Cleared Apr 01, 2009
BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM
K090759 · JCX
Biodrain Medical, Inc.
General & Plastic Surgery · 9d
Cleared Mar 31, 2009
ACUSON P50 ULTRASOUND SYSTEM
K083114 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 161d
Cleared Mar 31, 2009
DRILL FREE MMF SCREW
K083432 · DZL
KLS-Martin L.P.
Dental · 131d
Cleared Mar 31, 2009
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
K083446 · LLZ
Ziosoft, Inc.
Radiology · 130d
Cleared Mar 31, 2009
ASCEND
K083722 · OTP
Caldera Medical, Inc.
Obstetrics & Gynecology · 106d
Cleared Mar 31, 2009
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
K090026 · QSY
Hem Con Medical Technologies, Inc.
General & Plastic Surgery · 85d
Cleared Mar 31, 2009
PRELUDE ONE
K090106 · KLE
Danville Materials, Inc.
Dental · 89d
Cleared Mar 31, 2009
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
K090223 · LLZ
Icad, Inc.
Radiology · 60d