FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
88801–88824 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
K981929 · MST
The Binding Site, Ltd.
Immunology · 118d
Cleared Sep 03, 1998
SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM
K981973 · JKA
Ram Scientific
Chemistry · 90d
Cleared Sep 03, 1998
ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU)...
K981981 · GEI
Boston Scientific Corp
General & Plastic Surgery · 90d
Cleared Sep 03, 1998
VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER
K981994 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 87d
Cleared Sep 03, 1998
ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS
K982089 · LFR
Boehringer Mannheim Corp.
Chemistry · 80d
Cleared Sep 03, 1998
SANGUI BIOTECH, INC. CALCITONIN ELISA KIT
K982491 · JKR
Sangui Biotech, Inc.
Chemistry · 48d
Cleared Sep 03, 1998
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709 · MHJ
Alexon - Trend, Inc.
Microbiology · 30d
Cleared Sep 02, 1998
MEDSCI 3% GLUTARALDEHYDE
K974062 · MED
Medsci, Inc.
General Hospital · 310d
Cleared Sep 02, 1998
ACQPLAN
K974770 · MUJ
Philips Medical Systems (Cleveland),...
Radiology · 254d
Cleared Sep 02, 1998
AESCULAP HILAN MOTOR SYSTEM
K980686 · HBB
Aesculap, Inc.
Neurology · 191d
Cleared Sep 02, 1998
PIV SYSTEM
K981032 · LDQ
Medical Solutions, Inc.
General & Plastic Surgery · 167d
Cleared Sep 02, 1998
ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX...
K981970 · ELW
Cavex Holland BV
Dental · 90d
Cleared Sep 02, 1998
ACCU-CHEK COMFORT CURVE TEST STRIP
K982002 · LFR
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared Sep 02, 1998
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K982005 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 86d
Cleared Sep 02, 1998
NUCAMMA R+
K982044 · KPS
Is2 Research, Inc.
Radiology · 84d
Cleared Sep 02, 1998
NUCAMMA RX
K982045 · KPS
Is2 Research, Inc.
Radiology · 84d
Cleared Sep 02, 1998
MODEL MS-2 HANDPIECE
K982050 · EFB
Parkell, Inc.
Dental · 83d
Cleared Sep 02, 1998
VOLUMAX CT IMAGING SYSTEM
K982060 · JAK
Elscint, Inc.
Radiology · 83d
Cleared Sep 02, 1998
TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K982157 · LNH
Field Effects
Radiology · 75d
Cleared Sep 02, 1998
QUANTI-TEST SYSTEM
K982578 · SCL
Panatrex, Inc.
General Hospital · 41d
Cleared Sep 02, 1998
OMNI PRO LATEX SURGICAL GLOVE, POWDERED
K982613 · KGO
Omnigrace (Thailand) , Ltd.
General Hospital · 37d
Cleared Sep 02, 1998
PYRAMID
K982645 · EBF
Bisco, Inc.
Dental · 35d
Cleared Sep 02, 1998
PHILIPS BV300 SERIES RELEASE 2.1
K982706 · OXO
Philips Medical Systems, Inc.
Radiology · 29d
Cleared Sep 02, 1998
SOFT (HYDROPHILIC) CONTACT LENSES
K982774 · LPL
Cl-Tinters
Ophthalmic · 26d