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
106009–106032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1994
ELECTRODE, CUTANEOUS
K933801 · GXY
Cadwell Laboratories, Inc.
Neurology · 443d
Cleared Oct 21, 1994
ACUSON MODEL 2001
K934915 · IYN
Acuson Corp.
Radiology · 371d
Cleared Oct 21, 1994
R AND D BATTERIES
K935427 · JAF
R & D Batteries, Inc.
Radiology · 345d
Cleared Oct 21, 1994
MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5)
K941579 · JSM
Microtest
Microbiology · 203d
Cleared Oct 21, 1994
ALOKA SSD-2000 DIAGNOSTIC ULTRASOUND SYSTEM MODIFICATION
K941652 · IYN
Aloka Co., Ltd.
Radiology · 199d
Cleared Oct 21, 1994
IMPULSE SEALER PRODUCT LINE
K943370 · EJI
Ultradent Products, Inc.
Dental · 100d
Cleared Oct 21, 1994
DESKREM-1000
K943459 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 95d
Cleared Oct 21, 1994
PORTAREM 2000
K943460 · ETW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 95d
Cleared Oct 21, 1994
CEDIA DAU AMPHETAMINES ASSAY
K943993 · DKZ
Microgenics Corp.
Chemistry · 66d
Cleared Oct 21, 1994
PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT
K944078 · ESD
Argosy Electronics
Ear, Nose, Throat · 60d
Cleared Oct 21, 1994
PHILIPS TOMOSCAN SR5000
K944326 · JAK
Philips Medical Systems North...
Radiology · 53d
Cleared Oct 21, 1994
SCIMED TRIGUIDE GUIDE CATHETER
K944537 · DQY
Scimed Life Systems, Inc.
Cardiovascular · 36d
Cleared Oct 21, 1994
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION
K944723 · JWY
Alamar Biosciences, Inc.
Microbiology · 25d
Cleared Oct 20, 1994
DFS-2100
K932760 · LMA
Dba Systems, Inc.
Radiology · 499d
Cleared Oct 20, 1994
CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS
K932776 · JWH
Exactech, Inc.
Orthopedic · 499d
Cleared Oct 20, 1994
SSA-380A
K933743 · IYN
Toshiba America Medical Systems, In.C
Radiology · 443d
Cleared Oct 20, 1994
ANTERIOR SPINE SYSTEM
K934429 · KWQ
Buckman Co., Inc.
Orthopedic · 402d
Cleared Oct 20, 1994
MAC-LAB ELECTROPHYSIOLOGY MODULE OPTION
K935394 · DPS
Marquette Electronics, Inc.
Cardiovascular · 346d
Cleared Oct 20, 1994
EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT
K935726 · JWH
Exactech, Inc.
Orthopedic · 323d
Cleared Oct 20, 1994
CARPAL BOX
K936087 · KPR
Innovative Medical Technologies, Inc.
Radiology · 303d
Cleared Oct 20, 1994
HOWMEDICS DRG FEMORAL COMPONENT
K936126 · JDI
Howmedica, Inc.
Orthopedic · 301d
Cleared Oct 20, 1994
INFLATABLE RETENTION CUFF SPECULUM
K941391 · GBT
Innovatec Medical Corp.
Gastroenterology & Urology · 212d
Cleared Oct 20, 1994
HCG PREGNANCY ONE STEP TEST STRIP FOR OTC USE
K941765 · LCX
Tcpi, Inc.
Chemistry · 209d
Cleared Oct 20, 1994
SIGMA 8000 AND SIGMA 8002
K942162 · FRN
Sigma Intl.
General Hospital · 169d