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
130273–130296 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 10, 1989
LATEX EXAMINATION GLOVE
K890779 · LYY
T.K. Glove Products Co., Ltd.
General Hospital · 170d
Cleared Aug 10, 1989
OMNI-TRAK (PATIENT MONITOR)
K890817 · CCK
Invivo Research, Inc.
Anesthesiology · 174d
Cleared Aug 10, 1989
BIOTROL CALCIUM MONOREACTIF
K891061 · CJY
Biotrol, USA, Inc.
Chemistry · 162d
Cleared Aug 10, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891635 · LYY
Lucky Medsup, Inc.
General Hospital · 146d
Cleared Aug 10, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891701 · LYY
Sonley Glove Mfg. , Ltd.
General Hospital · 143d
Cleared Aug 10, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891822 · LYY
Kindly Assoc., Inc.
General Hospital · 139d
Cleared Aug 10, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892013 · LYY
Eastern Corp.
General Hospital · 133d
Cleared Aug 10, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892032 · LYY
Alizor, Inc. Dba Global Tech
General Hospital · 132d
Cleared Aug 10, 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892033 · LYY
Weiss Ent., Inc.
General Hospital · 132d
Cleared Aug 10, 1989
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
K892060 · JQP
Syva Co.
Chemistry · 134d