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
89641–89664 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 21, 1998
LASERLITE DIODE SURGICAL LASER
K981090 · GEX
Laserlite, LLC
General & Plastic Surgery · 26d
Cleared Apr 21, 1998
SYSTEM 7500 ABC ELECTROSURGICAL UNIT
K981220 · GEI
Aspen Laboratories, Inc.
General & Plastic Surgery · 18d
Cleared Apr 21, 1998
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
K981339 · JJY
Consolidated Technologies, Inc.
Chemistry · 8d
Cleared Apr 20, 1998
JTECH COMMANDER AND ALGOMETER
K971407 · HRW
J-Tech Medical, Inc.
Neurology · 369d
Cleared Apr 20, 1998
HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER
K971504 · DRF
J-Lloyd Medical, Inc.
Cardiovascular · 360d
Cleared Apr 20, 1998
ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
K973639 · DRF
J-Lloyd Medical, Inc.
Cardiovascular · 208d
Cleared Apr 20, 1998
INFUTEST 2000 INFUSION DEVICE ANALYZER
K980165 · MRZ
Datrend Systems, Inc.
General Hospital · 94d
Cleared Apr 20, 1998
AHMED GLAUCOMA VALVE, MODEL S3
K980657 · KYF
New World Medical, Inc.
Ophthalmic · 74d
Cleared Apr 20, 1998
POWER COINS GLOW IN THE DARK LIGATURES
K980864 · ECI
Ortho Kinetics Corp.
Dental · 46d