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
137977–138000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 04, 1987
BIOTIS (TM) BCYE
K874177 · KZI
Otisville Biopharm, Inc.
Microbiology · 50d
Cleared Dec 04, 1987
BIOTIS (TM) BCYE SELECTIVE
K874178 · JSJ
Otisville Biopharm, Inc.
Microbiology · 52d
Cleared Dec 04, 1987
HEMO-SOL
K874461 · KEM
Chem Pharm, Inc.
Pathology · 36d
Cleared Dec 04, 1987
BERNAFON COLIBRI, C-2H HEARING AIDS
K874589 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 25d
Cleared Dec 04, 1987
REMOTE-CONTROLLED UNIVERSAL DIAG. TABLE RS-100
K874639 · KXJ
Shimadzu Precision Instruments, Inc.
Radiology · 22d
Cleared Dec 03, 1987
MICRO-GUIDE
K870700 · DQO
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 287d
Cleared Dec 03, 1987
NUMED PTA CATHETERS
K871796 · LIT
NuMED, Inc.
Cardiovascular · 210d
Cleared Dec 03, 1987
MSS ENTERAL DELIVERY SET
K872921 · KNT
Medical Support, Inc.
Gastroenterology & Urology · 129d
Cleared Dec 03, 1987
TEMPORARY PACEMAKER ELECTRODE
K872972 · LDF
Oscor Medical Corp.
Cardiovascular · 127d
Cleared Dec 03, 1987
CHEMO-PORT NON-CORING NEEDLES
K873165 · FMI
Hdc Corp.
General Hospital · 114d
Cleared Dec 03, 1987
EDSLAB (R) OCCLUSION BALLOON CATHETER
K873485 · DQY
American Edwards Laboratories
Cardiovascular · 94d
Cleared Dec 03, 1987
STUBBIE STEERABLE GUIDEWIRE
K873543 · DQX
Target Therapeutics
Cardiovascular · 93d
Cleared Dec 03, 1987
MODEL 1010 PHYSIOLOGICAL SIGNAL TELEMETRY MONITOR
K873672 · DRG
Novametrix Medical Systems, Inc.
Cardiovascular · 83d
Cleared Dec 03, 1987
STERILIZED DENTAL BIT PACKAGING
K873698 · EJL
Florida Diamond Instruments Corp.
Dental · 80d
Cleared Dec 03, 1987
IVAC(R) STAR-FLOW(TM) VOLUMETRIC PUMP - MODEL 580+
K873776 · FRN
Y
General Hospital · 78d
Cleared Dec 03, 1987
MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE
K873921 · DTB
Intermedics, Inc.
Cardiovascular · 69d
Cleared Dec 03, 1987
'CATCH-IT' OR FECAL CONTAINMENT DEVICE
K873929 · EXB
Midwest Medical Co.
Gastroenterology & Urology · 69d
Cleared Dec 03, 1987
PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
K874045 · NWU
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 59d
Cleared Dec 03, 1987
STACHROM VIII:C TEST KIT
K874097 · GGP
American Bioproducts Co.
Hematology · 56d
Cleared Dec 03, 1987
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · DQA
Ohmeda Medical
Anesthesiology · 56d
Cleared Dec 03, 1987
CUMEVAC
K874410 · FFD
Cumes-Honikman Partnership
Gastroenterology & Urology · 36d
Cleared Dec 03, 1987
PHARMASEAL RUBBER URETHRAL CATHETER
K874517 · KOD
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 31d
Cleared Dec 02, 1987
BEAR VH-820 HUMIDIFIER
K873634 · BTT
Bear Medical Systems, Inc.
Anesthesiology · 84d
Cleared Dec 02, 1987
SPIRO ANALYZER ST-300
K873817 · BZG
Futuremed Div. of Future Impex Corp.
Anesthesiology · 72d