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
80113–80136 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 2001
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627 · DXE
Atrium Medical Corp.
Cardiovascular · 246d
Cleared Apr 26, 2001
EMBOL-X INTRODUCER, MODEL CF00200
K002973 · DYB
Embol-X, Inc.
Cardiovascular · 216d
Cleared Apr 26, 2001
SMARTSCREW MODEL 222006...227510
K003077 · HWC
Bionx Implants, Ltd.
Orthopedic · 205d
Cleared Apr 26, 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 160d
Cleared Apr 26, 2001
URS-1K (KETONE TESST)
K003987 · JIN
Teco Diagnostics
Chemistry · 121d
Cleared Apr 26, 2001
ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT...
K004010 · LFR
Roche Diagnostics Corp.
Chemistry · 121d
Cleared Apr 26, 2001
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000...
K004046 · DTP
Cobe Cardiovascular, Inc.
Cardiovascular · 118d
Cleared Apr 26, 2001
MAGNUM
K010252 · JFB
Magnum Equipment LLC
Physical Medicine · 90d
Cleared Apr 26, 2001
MEDIFACE PACS
K010259 · LLZ
Mediface Co., Ltd.
Radiology · 87d
Cleared Apr 26, 2001
THERASEED(R) PALLADIUM-103 IMPLANT
K010283 · KXK
Theragenics Corp.
Radiology · 86d
Cleared Apr 26, 2001
CAL/RAD MARK IV-DOSE CALIBRATOR 34-162 VEENSTRA MODEL # VDC-304
K010417 · KPT
Nuclear Assoc., Div. Inovision LP
Radiology · 73d
Cleared Apr 26, 2001
FREELITE LAMBDA FREE KIT
K010440 · DEH
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 26, 2001
FREELITE KAPPA FREE KIT
K010441 · DEH
The Binding Site, Ltd.
Immunology · 72d
Cleared Apr 26, 2001
PICCOLO CHLORIDE TEST SYSTEM
K010670 · CHJ
Abaxis, Inc.
Chemistry · 51d
Cleared Apr 26, 2001
MODIFICATION TO MIRAGE
K010726 · LLZ
Segami Corp., Inc.
Radiology · 45d
Cleared Apr 26, 2001
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K010955 · DPS
Boston Medical Technologies, Inc.
Cardiovascular · 27d
Cleared Apr 26, 2001
EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229
K010960 · DIC
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Apr 26, 2001
EMIT II PLUS METHADONE ASSAY, MODEL OSRE229
K010962 · DJR
Syva Co., Dade Behring, Inc.
Toxicology · 27d
Cleared Apr 26, 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · JTN
Hardy Diagnostics
Microbiology · 16d
Cleared Apr 25, 2001
GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005
K003206 · KXK
Proxima Therapeutics, Inc.
Radiology · 194d
Cleared Apr 25, 2001
ACTIVHEAL SCAR MANAGEMENT DRESSING
K010245 · MDA
Advanced Medical Solutions, Ltd.
General & Plastic Surgery · 90d
Cleared Apr 25, 2001
CRANIAL MOLDING ORTHOSIS
K010273 · MVA
Orthotic Solutions, Inc.
Neurology · 86d
Cleared Apr 25, 2001
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
K010451 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 69d
Cleared Apr 25, 2001
SYNTHES (USA) IMF SCREWS
K010527 · DZL
Synthes (Usa)
Dental · 62d