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
147505–147528 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1985
COULTER VOLUME ADAPTER
K851943 · GKL
Coulter Electronics, Inc.
Hematology · 119d
Cleared Aug 30, 1985
CAT. NO. S-5300-E BIRTHING BED
K852171 · KNC
Shampaine/Wilson
Obstetrics & Gynecology · 102d
Cleared Aug 30, 1985
FETA SCAN 1000 OBSTETRICAL IMAGER
K852439 · HEM
International Biomedics, Inc.
Obstetrics & Gynecology · 81d
Cleared Aug 30, 1985
ATRAUM WOUND DRESSING
K852614 · FRO
Axiom Medical, Inc.
General & Plastic Surgery · 71d
Cleared Aug 30, 1985
FOR USE IN EAR
K852695 · EWG
Minnesota Laser Corp.
Ear, Nose, Throat · 65d
Cleared Aug 30, 1985
KENDALL CURITY BURN PAD
K853145 · FPY
The Kendal Co.
General & Plastic Surgery · 32d
Cleared Aug 30, 1985
I.V. START KIT, I.V. RESTART KIT, PEDI-KIT,GERI-KI
K853242
U.S. Mfg. & Management, Inc.
General & Plastic Surgery · 29d
Cleared Aug 29, 1985
BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD
K844814 · DTD
Intermedics, Inc.
Cardiovascular · 261d
Cleared Aug 29, 1985
SYVA SOLID PHASE COLUMNS
K844948 · KEA
Syva Co.
Chemistry · 252d
Cleared Aug 29, 1985
MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN
K850968 · DTD
Medtronic Vascular
Cardiovascular · 174d
Cleared Aug 29, 1985
DEFI 502
K851485 · LDD
Robert Bosch Corp.
Cardiovascular · 136d
Cleared Aug 29, 1985
ELA MEDICAL PACING LEADS PMC 860 PMCF 860 PBCF860
K851731 · DTB
Ela Medical, Inc.
Cardiovascular · 126d
Cleared Aug 29, 1985
1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B
K851745 · ERA
Artiberia
Ear, Nose, Throat · 126d
Cleared Aug 29, 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845 · LDF
NuMED, Inc.
Cardiovascular · 125d
Cleared Aug 29, 1985
PORTABLE GASEOUS OXGYEN CONTAINER
K852663 · CAN
Cryogenic Assoc.
Anesthesiology · 66d
Cleared Aug 29, 1985
HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
K852867 · CKA
Hi Chem, Inc.
Chemistry · 52d
Cleared Aug 29, 1985
PEEL-AWAY SHEATH(A COMPONENT OF ARGON INTROD SET)
K852880 · DYB
Argon Medical Corp.
Cardiovascular · 51d
Cleared Aug 29, 1985
ORMCO TRANSMANDIBULAR IMPLANT
K852894 · MDL
Ormco Corp.
Dental · 51d
Cleared Aug 29, 1985
UNSCENTED ALWAYS PANTILINERS
K852985 · HHD
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 45d
Cleared Aug 29, 1985
PORTABLE OXYGEN UNIT
K853004 · CAW
B & F Medical Products, Inc.
Anesthesiology · 44d
Cleared Aug 29, 1985
PRECEPT ERYTHROMYCIN
K853053 · LTW
Austin Biological Laboratories
Microbiology · 41d
Cleared Aug 29, 1985
MEDIX ELECTRONIC NEBULIZING SYSTEM
K853071 · CCQ
Medix Corp.
Anesthesiology · 37d
Cleared Aug 29, 1985
KOTEX SECURITY TUBE TAMPON
K853192 · HEB
Kimberly-Clark Corp.
Obstetrics & Gynecology · 30d
Cleared Aug 29, 1985
PRECEPT AVGMENTIN
K853263 · LTW
Austin Biological Laboratories
Microbiology · 24d