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
96241–96264 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1996
PATRIOT
K963037 · LLZ
Infimed, Inc.
Radiology · 53d
Cleared Sep 27, 1996
MENTOR INJECTION PORT DETECTOR (IPD)
K963066 · LCJ
Mentor Corp.
General & Plastic Surgery · 51d
Cleared Sep 27, 1996
TESTOSTERONEE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC...
K963080 · CDZ
Bayer Corp.
Chemistry · 50d
Cleared Sep 27, 1996
DCA 2000 + MICROALBUMIN/CREATININE ASSAY
K963142 · JIR
Bayer Corp.
Chemistry · 45d
Cleared Sep 27, 1996
EBI THERMAL THERAPY SYSTEM
K963261 · ILO
Electro-Biology, Inc.
Physical Medicine · 38d
Cleared Sep 27, 1996
EUROLINE A-675 SERIS
K963519 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 24d
Cleared Sep 27, 1996
SIGMA DIAGNOSTICS ELECTROLYTE BUFFER
K963540 · JFL
Sigma Diagnostics, Inc.
Chemistry · 23d
Cleared Sep 27, 1996
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
K963542 · JGS
Sigma Diagnostics, Inc.
Chemistry · 23d
Cleared Sep 27, 1996
DYNAMIC EQ II - 2 CHANNEL WIDE DYNAMIC RANGE COMPRESSION
K963604 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 18d
Cleared Sep 26, 1996
EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03
K960902 · JOW
Eureduc
Cardiovascular · 205d
Cleared Sep 26, 1996
QUANTEX C4
K962198 · DBI
Instrumentation Laboratory CO
Immunology · 111d
Cleared Sep 26, 1996
QUANTEX IGG
K962202 · DEW
Instrumentation Laboratory CO
Immunology · 111d
Cleared Sep 26, 1996
DISPENS-O-DISC MEROPENEM
K963508 · JTN
Difco Laboratories, Inc.
Microbiology · 23d
Cleared Sep 25, 1996
ANKLE CALF EXERCISER PHLEBOPUMP
K952975 · BXB
Prevent Products, Inc.
Physical Medicine · 456d
Cleared Sep 25, 1996
INCSTAR 25-HYDROXYVITMIN D 1251 RIA
K953567 · MRG
Incstar Corp.
Chemistry · 422d
Cleared Sep 25, 1996
MT1A
K961382 · DZE
The Emerging Technologies Group
Dental · 190d
Cleared Sep 25, 1996
MT1
K961383 · DZE
The Emerging Technologies Group
Dental · 190d
Cleared Sep 25, 1996
MT-2
K961384 · DZE
The Emerging Technologies Group
Dental · 190d
Cleared Sep 25, 1996
MT-3A
K961385 · DZE
The Emerging Technologies Group
Dental · 190d
Cleared Sep 25, 1996
MT-2A
K961386 · DZE
The Emerging Technologies Group
Dental · 190d
Cleared Sep 25, 1996
MT-X
K961387 · DZE
The Emerging Technologies Group
Dental · 190d
Cleared Sep 25, 1996
AUTO SUTURE SURGIWAND
K961771 · GEI
United States Surgical, A Division of...
General & Plastic Surgery · 140d
Cleared Sep 25, 1996
QUANTEX C3
K962199 · CZW
Instrumentation Laboratory CO
Immunology · 110d
Cleared Sep 25, 1996
QUANTEX IGA
K962200 · CZP
Instrumentation Laboratory CO
Immunology · 110d