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
111025–111048 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 06, 1993
MODIFIED SITE DISPOSABLE DIAPHRAGM CASSETTE
K925921 · KYG
Site Microsurgical Systems, Inc.
Ophthalmic · 378d
Cleared Dec 06, 1993
OCUSYSTEM IIE
K926381 · HQC
Surgeon Design
Ophthalmic · 349d
Cleared Dec 06, 1993
ENDOCATH ELECTROPHYSIOLOGY CATHETER
K926549 · DRF
Endo-Therapeutics, Inc.
Cardiovascular · 340d
Cleared Dec 06, 1993
ARGENCO M
K931556 · EJT
Argen Precious Metals, Inc.
Dental · 251d
Cleared Dec 06, 1993
CARAPACE ANGIOGRAPHY TRAYS
K931629 · DQO
Carapace, Inc.
Cardiovascular · 248d
Cleared Dec 06, 1993
CARAPACE INSTRUMLENT AND INSTRUMENT SETS
K931824 · LRO
Carapace, Inc.
General & Plastic Surgery · 242d
Cleared Dec 06, 1993
PERMASOFT SOFT RELINE MATERIAL BY NU-DENT, INC.
K933831 · EBI
Nu-Dent, Inc.
Dental · 123d
Cleared Dec 06, 1993
REFLOTRON HEMOGLOBIN TEST TABS
K934064 · KHG
Boehringer Mannheim Corp.
Hematology · 159d
Cleared Dec 06, 1993
APTT-ES REAGENT
K934351 · GFO
Medical Diagnostic Technologies, Inc.
Hematology · 90d
Cleared Dec 06, 1993
CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
K934497 · JCN
R&D Systems, Inc.
Hematology · 83d
Cleared Dec 06, 1993
SPECTROLYSE FACTOR VII:C
K934584 · GGP
Meditech, Inc.
Hematology · 74d
Cleared Dec 03, 1993
GASTROINTESTINAL FEEDING TUBE
K920703 · KNT
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 654d
Cleared Dec 03, 1993
ENFUSE ENTERAL FEEDING TUBE
K922998 · KNT
Rusch, Inc.
Gastroenterology & Urology · 529d
Cleared Dec 03, 1993
NOVAMETRIX MODEL 510
K924626 · DQA
Novametrix Medical Systems, Inc.
Anesthesiology · 445d
Cleared Dec 03, 1993
NORTEC STER SALINE-O.9% SODIUM CHLOR FOR DEV IRRI
K925588 · LDQ
North American Sterilization &...
General & Plastic Surgery · 393d
Cleared Dec 03, 1993
NORTEC STERILE WATER FOR DEVICE IRRIGATION
K925593 · LDQ
North American Sterilization &...
General & Plastic Surgery · 393d
Cleared Dec 03, 1993
EEG ANALYZER
K925735 · GWS
Bio-Scan, Inc.
Neurology · 385d
Cleared Dec 03, 1993
DE LUXE
K925755 · HLJ
Rudolf Riester GmbH & Co. KG
Ophthalmic · 385d
Cleared Dec 03, 1993
COBAS CORE TSH EIA
K930776 · JLW
Roche Diagnostic Systems, Inc.
Chemistry · 290d
Cleared Dec 03, 1993
PROFILOMAT
K932109 · DXN
Qmed, Inc.
Cardiovascular · 214d
Cleared Dec 03, 1993
SYNELISA ANA PROFILE
K932206 · LJM
Elias U.S.A., Inc.
Immunology · 211d
Cleared Dec 03, 1993
8100 ANESTHETIC AGENT MONITOR
K932389 · CBS
Biochem International, Inc.
Anesthesiology · 200d
Cleared Dec 03, 1993
MODEL IPM-1 IMPEDANCE PULSE MONITOR
K932438 · DSB
Electro-Diagnostic Instruments
Cardiovascular · 198d
Cleared Dec 03, 1993
COBAS(R) CORE T3 EIA
K932608 · CDP
Roche Diagnostic Systems, Inc.
Chemistry · 189d