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
128209–128232 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1989
LATEX SURGICAL GLOVES
K892922 · KGO
Millimax Corp.
General Hospital · 223d
Cleared Nov 21, 1989
EPO-TRAC BY RADIOIMMUNOASSAY (RIA)
K893393 · GGT
Incstar Corp.
Chemistry · 204d
Cleared Nov 21, 1989
TENS PREP
K893604 · GYB
Smith & Nephew United, Inc.
Neurology · 189d
Cleared Nov 21, 1989
LATEX EXAMINATION GLOVES
K893937 · LYY
Sai Latex Private , Ltd.
General Hospital · 174d
Cleared Nov 21, 1989
STUDIO UNO
K894061 · EIA
Eurodent, Inc.
Dental · 167d
Cleared Nov 21, 1989
GAMMAMED IRIDIUM-192 SOURCE
K894381 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 127d
Cleared Nov 21, 1989
CARIBBEAN LATEX PRODUCTS EXAMINATION GLOVES
K894751 · LYY
Caribbean Latex Products, Inc.
General Hospital · 118d
Cleared Nov 21, 1989
AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP
K894794 · KPM
Vitaid, Ltd.
Gastroenterology & Urology · 116d
Cleared Nov 21, 1989
PURITAN-BENNETT OXYGEN CONCENTRATION INDICATOR
K895177 · CAW
Puritan Bennett Corp.
Anesthesiology · 103d
Cleared Nov 21, 1989
LATEX PATIENT EXAMINATION GLOVE
K895497 · LYY
Plymouth , Ltd.
General Hospital · 85d
Cleared Nov 21, 1989
M.D.I. ADAPTER
K895549 · BZA
Custom Connection Corp.
Anesthesiology · 69d
Cleared Nov 21, 1989
FREEWAY NEBULIZER COMPRESSOR
K895592 · CCQ
Lifecare Services, Inc.
Anesthesiology · 67d
Cleared Nov 21, 1989
FIBERVISION(TM)
K895733 · IYE
Fiber Imaging, Inc.
Radiology · 56d
Cleared Nov 21, 1989
SAS LATEX EXAMINATION GLOVES
K896217 · LYY
Sas Rubber Products Co., Ltd.
General Hospital · 22d
Cleared Nov 21, 1989
HWA TEH EXAMINATION GLOVES
K896251 · LYY
Hwa Teh Industrial Sdn. Bhd.
General Hospital · 22d
Cleared Nov 21, 1989
DSL I-PTH (DSL #8000)
K896294 · CEW
Diagnostic Systems Laboratories, Inc.
Chemistry · 21d
Cleared Nov 21, 1989
ELITE 1500 RADIOGRAPHIC TILTING TABLE
K896324 · IXR
Rms Div.
Radiology · 20d
Cleared Nov 20, 1989
ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG
K893040 · JWH
Orthomet, Inc.
Orthopedic · 210d
Cleared Nov 20, 1989
SOFT SUCTION ADAPTER
K895684 · GEA
Applied Medical Technologies
General & Plastic Surgery · 60d
Cleared Nov 20, 1989
ZIRCONIA CERAMIC HEAD ADD'L SIZES
K896204 · LZO
Richards Medical Co., Inc.
Orthopedic · 25d
Cleared Nov 20, 1989
ACUFEX FIXATION BUTTON
K896310 · KGS
Acufex Microsurgical, Inc.
General & Plastic Surgery · 19d
Cleared Nov 20, 1989
NOVA GEL(TM) T SM/RNP
K896459 · LLL
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 20, 1989
NOVA GEL(TM) T SS-A/SS-B
K896460 · LLL
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 20, 1989
NOVA GEL(TM) T SCL-70
K896461 · LLL
Inova Diagnostics, Inc.
Immunology · 7d