FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136225–136248 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1988
NOVA LITE(TM) ANA PLUS
K881339 · LLL
Inova Diagnostics, Inc.
Immunology · 23d
Cleared Apr 21, 1988
KIN-COM JR
K881388 · LBB
Chattanooga Group, Inc.
Neurology · 17d
Cleared Apr 21, 1988
THE ADVENTURER
K881410 · IOR
Westport Mobility Products, Inc.
Physical Medicine · 17d
Cleared Apr 21, 1988
ELECTRO-CAUTERY SUCTION TUBE
K881413 · GEI
Alto Development Corp.
General & Plastic Surgery · 17d
Cleared Apr 21, 1988
HEART CHECK APOLIPOPROTEIN-B
K881433 · MSJ
Northwest Biotech
Immunology · 16d
Cleared Apr 21, 1988
HEART CHECK APOLIPOPROTEIN A-1
K881434 · MSJ
Northwest Biotech
Immunology · 16d
Cleared Apr 21, 1988
FOLDING WHEELCHAIR
K881452 · IOR
Health Care Innovations, Inc.
Physical Medicine · 15d
Cleared Apr 21, 1988
KODAK SURECELL STREP A TEST KIT
K881457 · GTZ
Eastman Kodak Company
Microbiology · 15d
Cleared Apr 21, 1988
CRYOBIOLOGICAL FREEZER
K881465 · KSP
Cryodyne Technologies, Inc.
Pathology · 15d
Cleared Apr 21, 1988
MODIFIED PARACON(TM) CONCENTRATION KIT
K881649 · LKS
Para Scientific Co.
Microbiology · 6d
Cleared Apr 21, 1988
TISSUE SECTION ADHESIVE
K881659 · IFZ
Surgipath Medical Industries, Inc.
Pathology · 6d
Cleared Apr 21, 1988
IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS
K881675 · JZQ
Dynatech Laboratories, Inc.
Immunology · 3d
Cleared Apr 19, 1988
CSPI SPECIMEN TRAP (NON-STERILE)
K870874 · GCX
Custom Surgical Products, Inc.
General Hospital · 413d
Cleared Apr 19, 1988
SS-1000 POLYGRAPH
K872520 · DQA
Meramed Corp.
Anesthesiology · 299d
Cleared Apr 19, 1988
JAMES TENDOS (SYRINGE HOLDER)
K875297 · FMF
Med-Text Intl.
General Hospital · 111d
Cleared Apr 19, 1988
SAFECATH
K880260 · FOZ
Phase Medical Systems, Inc.
General Hospital · 88d
Cleared Apr 19, 1988
MICROTRAK CMV CULTURE CONFIRMATION TEST
K880290 · GQH
Syva Co.
Microbiology · 85d
Cleared Apr 19, 1988
HALF HOUR INFUSOR
K880625 · FRN
Baxter Healthcare Corp
General Hospital · 63d
Cleared Apr 19, 1988
BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
K880863 · GEI
New England Surgical Instrument Corp.
General & Plastic Surgery · 49d
Cleared Apr 19, 1988
AMYLASE 405 CATALOG NUMBER 301-34
K880867 · JFJ
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 49d
Cleared Apr 19, 1988
MODEL 2001 PHACOEMULSIFIER ASPIRATOR
K880968 · HQE
Mcghan Instrumed Corp.
Ophthalmic · 42d
Cleared Apr 19, 1988
EMIT VANCOMYCIN ASSAY
K881040 · LEH
Syva Co.
Toxicology · 39d
Cleared Apr 19, 1988
OPHTHALMIC SPECTACLE LENS BLANKS
K881225 · HQG
Beta Optical Co, Inc.
Ophthalmic · 28d
Cleared Apr 19, 1988
DECALCIFYING SOLUTION II
K881359 · KOX
Stephens Scientific
General & Plastic Surgery · 19d