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
128809–128832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 20, 1989
NOVA GEL(TM) T JO-1
K896462 · LLL
Inova Diagnostics, Inc.
Immunology · 7d
Cleared Nov 17, 1989
IDEIA HERPES SIMPLEX VIRUS TEST
K871877 · LGC
Boots-Celltech Diagnostics, Inc.
Microbiology · 918d
Cleared Nov 17, 1989
SPORVIEW CULTURE MEDIA
K890754 · FRC
Spsmedical Supply Corp.
General Hospital · 276d
Cleared Nov 17, 1989
TARGET OPIATES-R
K890978 · DJG
V-Tech, Inc.
Toxicology · 263d
Cleared Nov 17, 1989
MODEL 4000 ALTERNATING PRESSURE PUMP AND PAD
K891259 · FNM
Diamond Medical Equipment, Inc.
General Hospital · 254d
Cleared Nov 17, 1989
TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM
K892342 · IZH
Bay Shore Medical Equipment Corp.
Radiology · 226d
Cleared Nov 17, 1989
URETHRAL BALLOON DILATION CATHETER SET
K892855 · KOE
Cook Urological, Inc.
Gastroenterology & Urology · 213d
Cleared Nov 17, 1989
PROTOFLUOR Z
K893038 · JKJ
Helena Laboratories
Chemistry · 207d
Cleared Nov 17, 1989
OLYMPUS PK(TM) TP
K893124 · GMT
Fujirebio Diagnostics,Inc.
Microbiology · 206d
Cleared Nov 17, 1989
LATEX EXAMINATION GLOVES (MFG. ANHUI BENGBU LATEX)
K893351 · LYY
China National Medicines & Health...
General Hospital · 210d