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
90145–90168 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1998
DETACHABLE SILICONE BALLOON (DSB)
K964488 · MZQ
Target Therapeutics
Neurology · 529d
Cleared Apr 21, 1998
DETACHABLE SLICONE BALLOON (DSB)
K965071 · MZQ
Target Therapeutics
Neurology · 488d
Cleared Apr 21, 1998
SLT CL MD CONTACT LASER SYSTEM
K972548 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 287d
Cleared Apr 21, 1998
OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
K973896 · BSZ
Ohmeda Medical
Anesthesiology · 189d
Cleared Apr 21, 1998
DENTEK LD 15 LASERSYSTEM
K974057 · GEX
Dentek Lasersystems Produktions...
General & Plastic Surgery · 176d
Cleared Apr 21, 1998
CLK INT'L POWDER FREE LATEX EXAMINATION GLOVE
K974371 · LYY
Clk Intl., Inc.
General Hospital · 152d
Cleared Apr 21, 1998
ACKERMANN SURGICAL INSTRUMENTS
K974382 · GCJ
Ackermann Instrumente GmbH
General & Plastic Surgery · 151d
Cleared Apr 21, 1998
OPTICAL TRACKING SYSTEM (OTS)
K974602 · HAW
Radionics Software Applications, Inc.
Neurology · 133d
Cleared Apr 21, 1998
IMMULITE 2000 3RD GENERATION PSA
K974842 · LTJ
Diagnostic Products Corp.
Immunology · 118d
Cleared Apr 21, 1998
FERNO HEALTHCARE RECLINE-A-BATH 2
K980033 · ILJ
Ferno-Washington, Inc.
Physical Medicine · 106d
Cleared Apr 21, 1998
EXCEL NEURO WORKS
K980214 · GWQ
Excel Tech. , Ltd.
Neurology · 90d
Cleared Apr 21, 1998
NITOM LOCKING FACEBOW
K980245 · DZB
Ortho Kinetics Corp.
Dental · 88d
Cleared Apr 21, 1998
DERMABLATE ER: YAG LASER SYSTEM
K980361 · GEX
Aesculap-Meditec North America
General & Plastic Surgery · 82d
Cleared Apr 21, 1998
OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS...
K980465 · FDT
Olympus America, Inc.
Gastroenterology & Urology · 75d
Cleared Apr 21, 1998
INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401)
K980667 · CHH
Sigma Diagnostics, Inc.
Chemistry · 60d
Cleared Apr 21, 1998
ILAB 600 CLINICAL CHEMISTRY SYSTEM
K980757 · CGZ
Instrumentation Laboratory CO
Chemistry · 53d
Cleared Apr 21, 1998
HDL UNI-PAKS (PTA), CATALOGUE NUMBER 215-51
K980770 · LBR
Diagnostic Chemicals , Ltd.
Chemistry · 60d
Cleared Apr 21, 1998
SIMPLEX SALIVA ABSORBER/COLLECTOR, MODEL SSA-5
K980783 · KHR
Irt Management Corp.
Dental · 50d
Cleared Apr 21, 1998
CEDIA DAU MULTI-DRUG CALIBRATORS
K980853 · DKB
Boehringer Mannheim Corp.
Toxicology · 47d
Cleared Apr 21, 1998
IMMULITE 2000 CARCINOEMBRYONIC ANTIGEN (CEA) KIT
K980855 · DHX
Dpc Cirrus
Immunology · 47d
Cleared Apr 21, 1998
IL TEST PROTEIN C
K980875 · GGP
Instrumentation Laboratory CO
Hematology · 46d
Cleared Apr 21, 1998
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP,...
K980898 · DXC
Radi Medical Systems AB
Cardiovascular · 43d
Cleared Apr 21, 1998
PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES
K981035 · JKA
Sims Portex, Inc.
Chemistry · 33d
Cleared Apr 21, 1998
POWDERFREE GREEN NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981039 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 33d