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
111337–111360 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 05, 1993
VISI-SPOT
K932752 · JTO
J.S. Medical Assoc.
Microbiology · 170d
Cleared Nov 05, 1993
SYNELISA PROGESTERONE
K933128 · JLS
Elias U.S.A., Inc.
Chemistry · 130d
Cleared Nov 05, 1993
ACCESS VITAMIN B12 ASSAY
K933142 · CDD
Bio-Rad Laboratories, Inc.
Chemistry · 130d
Cleared Nov 05, 1993
POWERMATIC MAT PLATFORM
K933578 · INQ
Medical Device Inspection Co., Inc.
Physical Medicine · 106d
Cleared Nov 05, 1993
POWER WORK TABLE
K933580 · INQ
Medical Device Inspection Co., Inc.
Physical Medicine · 106d
Cleared Nov 05, 1993
POWERMATIC TREATMENT TABLE
K933581 · INQ
Medical Device Inspection Co., Inc.
Physical Medicine · 106d
Cleared Nov 05, 1993
OLYMPUS CHLORIDE REAGENT, MODIFICATION
K934136 · CHJ
Olympus Corp.
Chemistry · 78d
Cleared Nov 05, 1993
N-ASSAY TIA MICROALBUMIN CALIBRATOR SET
K934143 · JIX
Crestat Diagnostics, Inc.
Chemistry · 73d
Cleared Nov 04, 1993
DENTAL ROOT CANAL BACTERIALCIDAL LUBRICANT
K921713 · KJJ
A and V Ent.
Dental · 576d
Cleared Nov 04, 1993
ULTRA THIN BALLOON DILATATION CATHETER
K923611 · LIT
Boston Scientific Corp
Cardiovascular · 471d
Cleared Nov 04, 1993
OHMEDA ADAPTABLE CABLE W/DETACHABLE SENSOR
K930081 · DQO
Ohmeda Monitoring Systems
Cardiovascular · 301d
Cleared Nov 04, 1993
PERIOGLASS
K930115 · LYC
Usbiomaterials Corp.
Dental · 297d
Cleared Nov 04, 1993
FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR
K930171 · FEN
Fiberoptic Sensor Technlogies, Inc.
Gastroenterology & Urology · 295d
Cleared Nov 04, 1993
TALC DISPENSER SYRINGE
K930610 · KYZ
Nusurg, Inc.
General Hospital · 272d
Cleared Nov 04, 1993
LIGHTSPEED DENTAL HAND INSTRUMENT
K932529 · EKS
Lightspeed Endodontics
Dental · 163d
Cleared Nov 04, 1993
OLYMPUS GUIDE WIRE
K933110 · OCY
Olympus Corp.
Gastroenterology & Urology · 132d
Cleared Nov 03, 1993
FDP - SLIDEX DIRECT
K921989 · GHH
Biomerieux Vitek, Inc.
Hematology · 554d
Cleared Nov 03, 1993
ENERGIZED CONTAINER SYSTEM
K925418 · FPA
Abbott Laboratories
General Hospital · 372d
Cleared Nov 03, 1993
VICROSAFE 6 AND VICROSAFE 12
K930041 · FYD
Buffalo Filter Co., Inc.
General Hospital · 302d
Cleared Nov 03, 1993
MEDISON 88P DIAGNOSTIC ULTRASOUND IMAGING SYTEM
K930579 · IYO
Medison America, Inc.
Radiology · 272d
Cleared Nov 03, 1993
DURHAM
K930927 · FPA
Intl. Medical Consultants
General Hospital · 253d
Cleared Nov 03, 1993
DURHAM
K930974 · FPA
Intl. Medical Consultants
General Hospital · 252d
Cleared Nov 03, 1993
DURHAM
K931119 · FPA
Intl. Medical Consultants
General Hospital · 244d
Cleared Nov 03, 1993
CA-1000 AUTOMATED COAGULATION ANALYZER
K931149 · JPA
Toa Medical Electronics USA, Inc.
Hematology · 240d