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
135961–135984 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1988
SNAP(R) ROTAVIRUS DIAGNOSTIC KIT
K873565 · LIO
Molecular Biosystems, Inc.
Microbiology · 254d
Cleared May 13, 1988
REVISED IMMUDIA HEM-SP
K874482 · KHE
Schiff & Co.
Hematology · 206d
Cleared May 13, 1988
STAT-SAT
K874839 · DRY
Gish Biomedical, Inc.
Cardiovascular · 171d
Cleared May 13, 1988
HEADFIRST (CONDOM)
K874921 · HIS
Stual Products, Inc.
Obstetrics & Gynecology · 162d
Cleared May 13, 1988
TRICHOMATE(R) SUPER
K875138 · JWZ
Mercia Diagnostics , Ltd.
Microbiology · 150d
Cleared May 13, 1988
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
K875361 · LFZ
Disease Detection International, Inc.
Microbiology · 134d
Cleared May 13, 1988
RM-301 PATIENT MONITOR
K880498 · DRT
Ppg Industries, Inc.
Cardiovascular · 98d
Cleared May 13, 1988
VITEL III CM
K880533 · DXH
Equimed Corp.
Cardiovascular · 94d
Cleared May 13, 1988
AMBULATORY ECG DIGITAL MONITOR MODEL: TD-30
K880615 · DXH
Cardiotechnics, Inc.
Cardiovascular · 87d
Cleared May 13, 1988
SENSITITRE STABILITY PLATES
K880641 · JWY
Sensititre , Ltd.
Microbiology · 92d
Cleared May 13, 1988
ITE TYPE HEARING AID ABS MODEL
K880938 · ESD
A Better Sound Corp.
Ear, Nose, Throat · 67d
Cleared May 13, 1988
PRISMA DISPOSABLE 19 AND 20 GAUGE SCLERAL PLUGS
K880952 · LXP
Advanced Surgical Products, Inc.
Ophthalmic · 67d
Cleared May 13, 1988
ADVANCED SURGICAL 19 & 20 GAUGE DISP. SCLERAL PLUG
K880953 · LXP
Advanced Surgical Products, Inc.
Ophthalmic · 67d
Cleared May 13, 1988
INJECTOR HANDLE WITH SYRINGE
K880987 · DXT
Applied Vascular Devices, Inc.
Cardiovascular · 66d
Cleared May 13, 1988
ATS CRYPTOSPORIDIUM STAIN SET
K880989 · JTS
Alpha-Tec Systems, Inc.
Pathology · 66d
Cleared May 13, 1988
FITC MURINE MONOCLONAL ANTI-HSV BIVALENT IGG
K880996 · GQN
Whittaker Bioproducts, Inc.
Microbiology · 66d
Cleared May 13, 1988
MENTOR WET-FIELD*II COAGULATOR
K881001 · HQQ
Mentor O & O, Inc.
Ophthalmic · 65d
Cleared May 13, 1988
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS
K881011 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 64d
Cleared May 13, 1988
SUPER PIK MASSAGING PICK FOR ORAL HYGIENE
K881046 · JET
U.S. Dentek Corp.
Dental · 63d
Cleared May 13, 1988
FITC MURINE MONOCLONAL ANTI-HERPES TYPE 1 IGG
K881180 · GQN
Whittaker Bioproducts, Inc.
Microbiology · 66d
Cleared May 13, 1988
MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
K881186 · GHY
Helps Products, Inc.
Hematology · 53d
Cleared May 13, 1988
ADVANCE DIAGNOSTICS DISPOSABLE EYECUP
K881369 · LXQ
Advantage Diagnostics Corp.
Ophthalmic · 42d
Cleared May 13, 1988
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
K881592 · KPA
Wescor, Inc.
Pathology · 31d
Cleared May 13, 1988
AUDIOTONE MODEL ASP SECRET IN-THE-EAR HEARING AID
K881653 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 28d