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
129721–129744 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 10, 1989
UROVIEW II
K893475 · JAA
Oec-Diasonics, Inc.
Radiology · 98d
Cleared Aug 10, 1989
LATEX EXAMINATION GLOVES
K893592 · LYY
Excel Glove Co., Ltd.
General Hospital · 93d
Cleared Aug 10, 1989
SURGICARE (R) LATEX EXAMINATION GLOVES
K893651 · LYY
Inter Continental Health Care
General Hospital · 87d
Cleared Aug 10, 1989
LATEX EXAM GLOVES(MFG: SHANG HAI RONGTONG LATEX)
K893694 · LYY
Sinochem (Usa), Inc.
General Hospital · 86d
Cleared Aug 10, 1989
PATIENT EXAMINATION GLOVES
K893699 · LYY
Marshall Latex Products Private , Ltd.
General Hospital · 87d
Cleared Aug 10, 1989
EMAS GLOVE
K893724 · LYY
Exim Mfg. & Assoc. Services, Sdn Bhd
General Hospital · 85d
Cleared Aug 10, 1989
CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
K893760 · BZO
Nova-Ventrx
Anesthesiology · 83d
Cleared Aug 10, 1989
SURGICAL INSTRUMENT KIT, DISPOSABLE
K893814 · LRO
Bioseal
General & Plastic Surgery · 79d
Cleared Aug 10, 1989
POWDER FREE VINYL EXAMINATION GLOVES
K893883 · LYZ
Libent Co., Ltd.
General Hospital · 77d
Cleared Aug 10, 1989
EAGLE LASER, SURGICAL, NEODYMIUM DOPED YTTRIUM
K893956 · GEX
Living Technology, Inc.
General & Plastic Surgery · 70d
Cleared Aug 10, 1989
CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY
K894002 · LIN
Baxter Healthcare Corp
Microbiology · 66d
Cleared Aug 10, 1989
SHARPLAN CO2 LAPAROSCOPIC PROBE MODEL 792 TO 792BX
K894066 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 63d
Cleared Aug 10, 1989
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS
K894210 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 52d
Cleared Aug 10, 1989
SHARPLAN SERIES 2900 SYNTHETIC CONTACT TIPS
K894211 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 52d
Cleared Aug 10, 1989
MODIFIED PATIENT EXAMINATION GLOVES
K894311 · LYY
Safeskin Corp.
General Hospital · 27d
Cleared Aug 10, 1989
ZIMMER TENS
K894388 · GZJ
American Imex
Neurology · 24d
Cleared Aug 10, 1989
WELCON LIGHT HANDLE
K894397 · FTA
Welcon, Inc.
General & Plastic Surgery · 21d
Cleared Aug 10, 1989
AMMEL STERILE SURGEON'S GLOVES
K894501 · KGO
Mauricio Menconi
General Hospital · 22d
Cleared Aug 10, 1989
SCANLISA HUMAN CRP ELISA KIT
K894573 · DCK
Immuntech A/S
Immunology · 20d
Cleared Aug 10, 1989
TECHNICON DPA-1 SYSTEM RF METHOD
K894574 · DHR
Technicon Instruments Corp.
Immunology · 20d
Cleared Aug 10, 1989
GENERAL SURGICAL INSTRUMENTS
K894670 · DXC
Nopa Instruments
Cardiovascular · 69d
Cleared Aug 10, 1989
PENLON IDP PRESSURE FAILURE ALARM
K894689 · CAP
Penlon, Inc.
Anesthesiology · 17d
Cleared Aug 09, 1989
INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD
K885179 · DYB
Baxter Healthcare Corp
Cardiovascular · 238d
Cleared Aug 09, 1989
INTERMEDICS APR(TM) II FEMORAL COMPONENT
K890450 · JDJ
Intermedics Orthopedics
Orthopedic · 191d