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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
122305–122328 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1991
LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS
K905542 · EFB
Lares Research, Inc.
Dental · 90d
Cleared Mar 11, 1991
LARES APOLLO CS/CP/C
K905543 · EBZ
Lares Research, Inc.
Dental · 90d
Cleared Mar 11, 1991
NEUROMED OCTRODE MODEL MNR-88B/88C NEUROSTIM SYST
K905596 · GZB
Neuromed, Inc.
Neurology · 88d
Cleared Mar 11, 1991
BIOTROL LACTATE DEHYDROGENASE (L-P)
K905683 · CFJ
Biotrol, USA, Inc.
Chemistry · 82d
Cleared Mar 11, 1991
SIEMENS ETCO2 CARTRIDGE
K905775 · CCK
Siemens Medical Electronics
Anesthesiology · 74d
Cleared Mar 11, 1991
ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS
K910085 · DKB
Roche Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Mar 11, 1991
CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED
K910147 · CGX
Olympus Corp.
Chemistry · 56d
Cleared Mar 11, 1991
HEMOCARD CONTROL
K910431 · JCM
Isolab, Inc.
Hematology · 38d
Cleared Mar 11, 1991
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K910484 · JWY
Alamar
Microbiology · 33d
Cleared Mar 11, 1991
LOOP RETRIEVER
K910603 · FFL
Annex Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Mar 11, 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
K910638 · CDT
Em Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Mar 11, 1991
ABUSCREEN(R) ONLINE CONTROLS
K910689 · LAS
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 11, 1991
ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000)
K910756 · DKZ
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Mar 11, 1991
BACTEC NR-860
K910835 · JTA
Bd Becton Dickinson Vacutainer...
Microbiology · 12d
Cleared Mar 11, 1991
PVC VINYL GLOVE
K910891 · LYZ
Pioneer Sundries Products , Ltd.
General Hospital · 7d
Cleared Mar 08, 1991
IPAZYME(TM) CHLAMYDIA TRUE IGM(TM)
K901975 · LKH
Savyon Diagnostics , Ltd.
Microbiology · 311d
Cleared Mar 08, 1991
PATIENT EXAMINATION GLOVES
K904697 · LYY
Shamrock Marketing Co.
General Hospital · 143d
Cleared Mar 08, 1991
HIGH SPEED CORE CUT BIOPSY GUN
K905556 · FCG
Uni-Quatro Industries Canada, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 08, 1991
CCC CROWN-CORE-CUT-NEEDLE
K905557 · KNW
Uni-Quatro Industries Canada, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 08, 1991
PHILIPS GYROVIEW-HR IMAGING WORKSTATION
K905603 · LNH
Philips Medical Systems, Inc.
Radiology · 85d
Cleared Mar 08, 1991
543 SERIES BTE
K905680 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 79d
Cleared Mar 08, 1991
STRATOFUSE PCA INFUSER
K905696 · FRN
Strato Medical Corp.
General Hospital · 77d
Cleared Mar 08, 1991
NON-STERILE PATIENT EXAMINATION GLOVES
K905755 · LYY
Superior Healthcare Group, Inc.
General Hospital · 71d
Cleared Mar 08, 1991
POST AURICULAR HEARING AID MODEL PICO SC-H
K910028 · ESD
Phonak, Inc.
Ear, Nose, Throat · 63d