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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
105001–105024 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 29, 1994
LYNX LOW-SPEED HANDPIECE
K940261 · EFB
Mti Precision Products
Dental · 342d
Cleared Dec 29, 1994
MADDEN SURGICAL THIMBLE
K940907 · KNA
Kelley-Gilmer Medical Corp.
Obstetrics & Gynecology · 308d
Cleared Dec 29, 1994
KAVO SYSTEMATICA 1060
K940950 · KLC
Kavo America
Dental · 304d
Cleared Dec 29, 1994
GLUCOSE QVET
K942963 · CFR
Prisma Systems
Chemistry · 189d
Cleared Dec 29, 1994
LACTATE DEHYDROGENASE QVET
K942964 · CFJ
Prisma Systems
Chemistry · 189d
Cleared Dec 29, 1994
ALKALINE PHOSPHATASE (ALKP) QVET
K942997 · CJE
Prisma Systems
Chemistry · 189d
Cleared Dec 29, 1994
MAGNESIUM QVET
K943001 · JGJ
Prisma Systems
Chemistry · 189d
Cleared Dec 29, 1994
BUN QVET
K943042 · CDN
Prisma Systems
Chemistry · 185d
Cleared Dec 29, 1994
SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM
K943637 · ITX
Aloka Co., Ltd.
Radiology · 155d
Cleared Dec 29, 1994
STAT PROFILE ULTRA 11 ANALYZER
K943643 · CHL
Nova Biomedical Corp.
Chemistry · 155d
Cleared Dec 29, 1994
DYE CHECK STRIPS 545-630
K943729 · JJY
Awareness Technology, Inc.
Chemistry · 149d
Cleared Dec 29, 1994
NEEDLE GUIDE
K943863 · IYN
Biopsys Medical, Inc.
Radiology · 143d
Cleared Dec 29, 1994
AUTO-LYTE METHADONE DIA
K944056 · DJR
Solarcare Technologies Corp,Inc.
Toxicology · 132d
Cleared Dec 29, 1994
CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST
K944075 · DIS
Beckman Instruments, Inc.
Toxicology · 177d
Cleared Dec 29, 1994
CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS
K944086 · LDJ
Beckman Instruments, Inc.
Toxicology · 177d
Cleared Dec 29, 1994
DENTAL OPERATIVE UNIT ACCESORIES
K944271 · EIA
Dci Intl.
Dental · 121d
Cleared Dec 29, 1994
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
K944359 · ESD
Rexton, Inc.
Ear, Nose, Throat · 113d
Cleared Dec 29, 1994
STERRAD CHEMICAL INDICATOR TAPE
K945190 · JOJ
Advanced Sterilization Products
General Hospital · 66d
Cleared Dec 29, 1994
PULP CANAL SEALER EWT
K945244 · EMA
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Dec 29, 1994
TRUJECT
K945284 · FMI
Clive Craig Co.
General Hospital · 59d
Cleared Dec 29, 1994
DYRACT(TM) MATERIAL
K945364 · EBF
Denstply Detrey-Dedent
Dental · 69d
Cleared Dec 29, 1994
WHITE STAR
K945401 · EJT
Jeneric/Pentron, Inc.
Dental · 56d
Cleared Dec 29, 1994
OPTIGUARD
K945539 · EBF
Sybron Dental Specialties, Inc.
Dental · 45d
Cleared Dec 29, 1994
GUARDIAN II GLOVE
K945577 · LZC
Guardian Group, Inc.
General Hospital · 45d