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
154393–154416 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 11, 1984
IL MODEL 840 MICROPROCESSOR LOADER
K833505 · JQW
Instrumentation Laboratory CO
Chemistry · 92d
Cleared Jan 11, 1984
REAGENT TESTS STRIP COMBINATIONS
K833521 · JJB
Syn-Kit, Inc.
Chemistry · 92d
Cleared Jan 11, 1984
CENTRAL VEIN CATH. TRAY CC-20-1420
K833573 · DQY
Intermed, Inc.
Cardiovascular · 91d
Cleared Jan 11, 1984
PERCUTANEOUS SHEATH INTRODUCER TRAYS
K833574 · DQX
Intermed, Inc.
Cardiovascular · 91d
Cleared Jan 11, 1984
GOLD ALLIGATOR FORCEPS
K833608 · KAE
Microtek Medical, Inc.
Ear, Nose, Throat · 91d
Cleared Jan 11, 1984
PORTA PULSE III #D320
K833751 · LDD
Medical Research Laboratories, Inc.
Cardiovascular · 77d
Cleared Jan 11, 1984
HAMILTON PEDIATRICS SCALE
K833754 · FRW
Befour, Inc.
General Hospital · 77d
Cleared Jan 11, 1984
SOMAS CHLORIDE ASSAY KIT
K833787
Somas Medical Industries, Inc.
Chemistry · 72d
Cleared Jan 11, 1984
AMERICAN GOLD SERIES AUTOCLAVE
K833837 · FLE
Tuttnauer Co. , Ltd.
General Hospital · 69d
Cleared Jan 11, 1984
MICRO INFUSION SET
K833949 · FPA
Deltec Systems, Inc.
General Hospital · 57d
Cleared Jan 11, 1984
CVA
K833967 · JSJ
Remel Co.
Microbiology · 56d
Cleared Jan 11, 1984
STRIP SPLITTER II -HALF WIDTH CARRIER
K834150 · JJQ
Larken Industries, Inc.
Hematology · 41d
Cleared Jan 10, 1984
ATAC 3000
K832115 · JJE
Turpen Laboratory Systems, Inc.
Chemistry · 194d
Cleared Jan 10, 1984
TELEMETRY SYS SERIES 7700 ECG
K832817 · DRG
Marquette Electronics, Inc.
Cardiovascular · 144d
Cleared Jan 10, 1984
INVASIVE MONITORING KITS
K832907 · DRS
American Pharmaseal Div. Ahsc
Cardiovascular · 134d
Cleared Jan 10, 1984
GELENDER VACUUM FIXATION RING SYS
K832912 · HNH
Miami Eye Technology, Inc.
Ophthalmic · 134d
Cleared Jan 10, 1984
WELLCOGEN N. MENINGITIDIS A,C,Y W135
K833063 · GTJ
Wellcome Diagnostics
Immunology · 123d
Cleared Jan 10, 1984
WELLCOGEN H. INFLUENZAL ZL21
K833077 · GRD
Wellcome Diagnostics
Immunology · 123d
Cleared Jan 10, 1984
AMBULATORY MONITORING DEVICE
K833162 · DSI
Oxford Medilog, Inc.
Cardiovascular · 116d
Cleared Jan 10, 1984
SENTINEL SYSTEMS
K833395 · DXG
Quantitative Medicine, Inc.
Cardiovascular · 102d
Cleared Jan 10, 1984
SYRINGE
K833399 · FMF
I M, Inc.
General Hospital · 97d
Cleared Jan 10, 1984
BDH UNIPOLAR FEMORAL COMPONENT A2
K833403 · KWL
Carbomedics, Inc.
Orthopedic · 102d
Cleared Jan 10, 1984
KINETIX MOUTHPIECE
K833420 · BYP
Kinetix
Anesthesiology · 99d
Cleared Jan 10, 1984
REMOLDABLE CRANIOMANDIBULAR APPLIANCE
K833455 · KMY
Jeffrey H. Attlin
Dental · 105d