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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
129673–129696 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1989
OLYMPUS ISE MODULE FOR AU5000
K893628 · CGZ
Olympus Corp.
Chemistry · 92d
Cleared Aug 11, 1989
DIRECT BILIRUBIN REAGENT
K893730 · CIG
Medical Analysis Systems, Inc.
Chemistry · 86d
Cleared Aug 11, 1989
QUIDEL REFLECTANCE ANALYZER
K893738 · JJQ
Quidel Corp.
Chemistry · 86d
Cleared Aug 11, 1989
LAURIER SANITARY NAPKIN
K893773 · HHD
Kao Corp.
Obstetrics & Gynecology · 81d
Cleared Aug 11, 1989
PEAK FLOW RATE METER
K893827 · FFG
Laytech Medical Co.
Gastroenterology & Urology · 79d
Cleared Aug 11, 1989
3D DENTAL DIAMOND ROTARY INSTRUMENTS
K893844 · DZP
Lustgarten Multi-Tech International,...
Dental · 78d
Cleared Aug 11, 1989
FLOCARE
K893875 · BYD
Mega-Tech Intl., Inc.
Anesthesiology · 77d
Cleared Aug 11, 1989
FD 350 DENTAL STOOL
K893945 · KLC
Oriola OY Finndent
Dental · 72d
Cleared Aug 11, 1989
ROCHE REAGENT FOR TRIGLYCERIDES
K893973 · CDT
Roche Diagnostic Systems, Inc.
Chemistry · 70d
Cleared Aug 11, 1989
DERMACARE TIE HOLDER
K893995 · KGS
Dermacare
General & Plastic Surgery · 67d
Cleared Aug 11, 1989
SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS
K894042 · GXY
Labeltape Meditect, Inc.
Neurology · 66d
Cleared Aug 11, 1989
SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS
K894043 · GXY
Labeltape Meditect, Inc.
Neurology · 66d
Cleared Aug 11, 1989
STERILE HAND COVER
K894064 · LYU
Sage Products, Inc.
General Hospital · 64d
Cleared Aug 11, 1989
LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II
K894078 · JJY
Bio-Rad
Chemistry · 56d
Cleared Aug 11, 1989
GOMCO CIRCUMCISION CLAMP
K894201 · HFX
Zinnanti Surgical Instruments, Inc.
Obstetrics & Gynecology · 56d
Cleared Aug 11, 1989
STORZ DAISYPLUS SERIES MICROSURGICAL SYSTEMS
K894278 · HQE
Storz Instrument Co.
Ophthalmic · 49d
Cleared Aug 11, 1989
UROPUMP* FLUID MANAGEMENT SYSTEM
K894363 · FDC
Orthoconcept, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 11, 1989
EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE
K894404 · DKZ
Syva Co.
Toxicology · 25d
Cleared Aug 11, 1989
BATES BLANKET
K894433 · KKX
Joe B. Bates, MD, FAAP
General Hospital · 25d
Cleared Aug 11, 1989
MASCOT O.R. TOWEL
K894436 · KKX
Mascot, Inc.
General Hospital · 25d
Cleared Aug 11, 1989
SHIRT, OPERATING, SURGICAL
K894599 · FYA
Miroz Industries Co.
General Hospital · 22d
Cleared Aug 10, 1989
DERMATRON SKIN RESISTANCE METER
K883112 · GZO
Raymar Electronics
Neurology · 381d
Cleared Aug 10, 1989
SURGITEK FLAT T-SPAN
K884746 · LCJ
Medical Engineering Corp.
General & Plastic Surgery · 269d
Cleared Aug 10, 1989
EXAMINATION GLOVES
K890393 · LYY
Sumirubber Industries (Kedah) Sdn. Bhd.
General Hospital · 197d