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
95857–95880 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 29, 1996
SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1
K963533 · JIX
Sigma Diagnostics, Inc.
Chemistry · 55d
Cleared Oct 29, 1996
PT SYNTHETIC MEDICAL GLOVES, POWDER FREE
K963751 · LYZ
Shanghai PT Plastics Enterprise...
General Hospital · 41d
Cleared Oct 29, 1996
PM SYNTHETIC MEDICAL GLOVES, POWDER FREE
K963797 · LYZ
Shanghai PM Plastics Enterise Co., Ltd.
General Hospital · 36d
Cleared Oct 28, 1996
VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM
K954448 · FRA
Schiff & Co.
General Hospital · 399d
Cleared Oct 28, 1996
EUREDUC PNEUMATIC DRAINAGE SYSTEM
K954788 · JOW
Eureduc
Cardiovascular · 376d
Cleared Oct 28, 1996
PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING...
K960299 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 280d
Cleared Oct 28, 1996
MEDI-TRACE 200, MEDI-TRACE 200-30
K960968 · DRX
Graphic Controls Corp.
Cardiovascular · 231d
Cleared Oct 28, 1996
SYSMEX UF-100
K961054 · LKM
Sysmex Corp.
Pathology · 224d
Cleared Oct 28, 1996
CONVERTORS POLYOLEFIN FABRIC GOWNS
K961341 · FYA
Baxter Healthcare Corp
General Hospital · 203d
Cleared Oct 28, 1996
BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MULTI-CHAMBER...
K961425 · ILO
Bio Compression Systems, Inc.
Physical Medicine · 199d
Cleared Oct 28, 1996
BIO BOOST
K961426 · IRP
Bio Compression Systems, Inc.
Physical Medicine · 199d
Cleared Oct 28, 1996
RADIAS GALT TEST
K961432 · JJX
Bio-Rad
Chemistry · 196d
Cleared Oct 28, 1996
ACUPUNCTURE NEEDLES
K961677 · MQX
K.S. Choi Corp.
General Hospital · 181d
Cleared Oct 28, 1996
PATELLOFEMORAL JOINT PROSTHESIS
K962190 · KRR
Intermedics Orthopedics
Orthopedic · 144d
Cleared Oct 28, 1996
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE
K962714 · JOH
Passy-Muir, Inc.
Anesthesiology · 108d
Cleared Oct 28, 1996
GAMMACON IMAGE TRANSLATION SYSTEM
K962955 · KPS
Medical Imaging Technology Assoc., Inc.
Radiology · 90d
Cleared Oct 28, 1996
FUJI MEDICAL DRY IMAGER FM-DP 2636
K962967 · LMC
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared Oct 28, 1996
TBD
K963026 · HSB
Acu Med, Inc.
Orthopedic · 84d
Cleared Oct 28, 1996
RETINAL DETACHMENT IMPLANTS
K963219 · HQX
Fci Ophthalmics, Inc.
Ophthalmic · 73d
Cleared Oct 28, 1996
VACUUM CUP (004SD)
K963287 · HDB
Swift Delivery Products
Obstetrics & Gynecology · 68d
Cleared Oct 28, 1996
STRAP WEDGE
K963526 · FMQ
Alimed, Inc.
General Hospital · 54d
Cleared Oct 28, 1996
LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS
K963740 · JEY
Howmedica Leibinger, Inc.
Dental · 41d
Cleared Oct 28, 1996
OVATION AGC-2
K963818 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 28, 1996
OVATION ASP
K963819 · ESD
Orsonique, Inc.
Ear, Nose, Throat · 35d