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
143857–143880 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 1986
MODIFIED FETAL MONITOR MODEL FM-2
K861556 · HGM
Advantage Medical Systems, Inc.
Obstetrics & Gynecology · 73d
Cleared Jul 07, 1986
TDX REA LACTIC ACID
K861741 · KHP
Abbott Laboratories
Chemistry · 62d
Cleared Jul 07, 1986
V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II
K861756 · JJW
Texas Immunology, Inc.
Chemistry · 62d
Cleared Jul 07, 1986
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
K861773 · DGB
Zygotek Systems, Inc.
Immunology · 61d
Cleared Jul 07, 1986
VANILMANDELIC ACID (VMA) REAGENT SET
K861962 · CDF
Sterling Diagnostics, Inc.
Chemistry · 48d
Cleared Jul 07, 1986
CIRCUIT ANES. BREATHING & COMPONENTS
K862003 · CAI
Vital Signs, Inc.
Anesthesiology · 41d
Cleared Jul 07, 1986
MODIFIED COTROPIN RADIOIMMUNOASSAY KIT
K862180 · CEP
Clinetics Corp.
Chemistry · 28d
Cleared Jul 07, 1986
RESUSCITATOR MODELS 10400/10500/10600/10700/10800
K862192 · BTL
U.O. Equipment Co.
Anesthesiology · 28d
Cleared Jul 07, 1986
LAURIER OVERNIGHT SANITARY NAPKIN (MODIFICATION)
K862270 · HHD
Kao Corp.
Obstetrics & Gynecology · 24d
Cleared Jul 07, 1986
LAURIER SAFETY LONG SANITARY NAPKIN (MODIFICATION)
K862271 · HHD
Kao Corp.
Obstetrics & Gynecology · 24d
Cleared Jul 07, 1986
THE D & C PAD-SAC
K862297 · HCY
Nu-Gyn-Tek, Inc.
Obstetrics & Gynecology · 20d
Cleared Jul 07, 1986
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93
K862308 · DLZ
Em Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Jul 07, 1986
HBDH (OPTIMIZED) REAGENT
K862319 · JMK
Sigma Chemical Co.
Chemistry · 19d
Cleared Jul 07, 1986
CHLAMYDIA KIT, STD KIT
K862322 · HHT
Intl. Cytobrush, Inc.
Obstetrics & Gynecology · 18d
Cleared Jul 07, 1986
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
K862349 · DIP
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Jul 07, 1986
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
K862350 · KLS
Em Diagnostic Systems, Inc.
Toxicology · 17d
Cleared Jul 07, 1986
EPICATH
K862358 · KNE
Hdc Corp.
Obstetrics & Gynecology · 14d
Cleared Jul 07, 1986
NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE
K862365 · HIO
Swemed Laboratories, Inc.
Obstetrics & Gynecology · 13d
Cleared Jul 03, 1986
SOMATOSENSORY EVOKED POTENTIAL STIMULATOR
K855232 · GWF
Neuroscience, Inc.
Neurology · 185d
Cleared Jul 03, 1986
NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESS
K860472 · IWE
Nuclear Diagnostics, Inc.
Radiology · 147d
Cleared Jul 03, 1986
GEN-PROBE MYCOPLASMA PNEUMONIA RAPID DETECT SYSTEM
K860574 · LQG
Gen-Probe, Inc.
Microbiology · 139d
Cleared Jul 03, 1986
7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER)
K861228 · ITX
General Electric Co.
Radiology · 93d
Cleared Jul 03, 1986
COMBISON R 320A
K861376 · IYO
Cone Instruments, Inc.
Radiology · 85d
Cleared Jul 03, 1986
EMPI MODEL 720 NMS, TENS
K861451 · GZJ
Empi
Neurology · 76d