FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167017–167040 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1980
BEHIND EAR HEARING AID MODEL E24C1
K800244 · ESD
Oticon Corp.
Ear, Nose, Throat · 43d
Cleared Mar 19, 1980
CEPH LACTAM DISK
K800287 · JSF
Remel Co.
Microbiology · 37d
Cleared Mar 19, 1980
POWER PACK
K800314 · KIJ
Black & Decker(Tm)
Orthopedic · 36d
Cleared Mar 19, 1980
DUAL MPC CHARGER
K800315 · KIJ
Black & Decker(Tm)
Orthopedic · 36d
Cleared Mar 19, 1980
CARDIOPLEGIA DELIVERY SYSTEM
K800377 · DTR
3M Health Care, Sarns
Cardiovascular · 27d
Cleared Mar 19, 1980
REFRIG. CENTRIFUGE (DRUCKER MODEL)
K800381 · JQC
Coulter Electronics, Inc.
Chemistry · 26d
Cleared Mar 19, 1980
SMAC SYSTEM, T4 METHOD
K800384 · KLI
Technicon Instruments Corp.
Chemistry · 26d
Cleared Mar 19, 1980
ANALYTE T4-THYROXINE
K800385 · CDX
Technicon Instruments Corp.
Chemistry · 26d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST
K800426 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT
K800427 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/CYSTEINE AND
K800428 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
TRYPTIC SOY BROTH W/C02,CYSTEINE & 1%
K800429 · JSC
Abbott Laboratories
Microbiology · 22d
Cleared Mar 19, 1980
T3 SOLID PHASE RADIOIMMUNOASSAY KIT
K800436 · CDP
Bd Becton Dickinson Vacutainer...
Chemistry · 21d
Cleared Mar 19, 1980
PERCUTANEOUS INTRODUCER SET
K800462 · DRE
Medical Components, Inc.
Cardiovascular · 19d
Cleared Mar 19, 1980
STIM-EX 201
K800486 · IPF
Th Charters, Inc.
Physical Medicine · 15d
Cleared Mar 19, 1980
PHENCYCLIDINE DIRECT BLOOD RIA KIT
K800514 · LCL
Immunalysis Corporation
Toxicology · 14d
Cleared Mar 19, 1980
DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM.
K800516 · KIE
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 14d
Cleared Mar 18, 1980
EMERGIENCY RESUSCITATOR/INHALOR W/ASPIR.
K800456 · BTL
Khi, Inc.
Anesthesiology · 18d
Cleared Mar 18, 1980
VINYL POLYSILOXANE IMPRESSION MATERIAL
K800485 · ELW
3M Company
Dental · 14d
Cleared Mar 18, 1980
VSM-1 PHYSIOLOGICAL MONITOR
K800492 · DPS
Physio-Control Corp.
Cardiovascular · 14d
Cleared Mar 18, 1980
NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS
K800494 · HSD
Depuy, Inc.
Orthopedic · 14d
Cleared Mar 18, 1980
SUCTION CATHETER
K800503 · BSY
Medi-Craft , Ltd.
Anesthesiology · 14d
Cleared Mar 18, 1980
OXYGEN CONNECTING TUBES
K800504 · BYX
Medi-Craft , Ltd.
Anesthesiology · 14d
Cleared Mar 18, 1980
DENTAL STOOLS, #'S P2212, P1121, ETC.
K800520
Vacudent Sales Corp.
Dental · 12d