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
135361–135384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1988
HR VACUTRAC
K881201 · JKA
Icu Medical, Inc.
Chemistry · 56d
Cleared May 16, 1988
PROBE SHEATH FOR ADMS ULTRASOUND PROBE
K881208 · IYO
Advanced Diagnostic Medical Systems,...
Radiology · 56d
Cleared May 16, 1988
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
K881255 · JGS
Nova Biomedical Corp.
Chemistry · 54d
Cleared May 16, 1988
BIOTROL CK MONOEACTIF
K881267 · JHX
Biotrol, USA, Inc.
Chemistry · 53d
Cleared May 16, 1988
URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II
K881275 · JJY
Fisher Scientific Co., LLC
Chemistry · 52d
Cleared May 16, 1988
CONDOM-MATE VAGINAL LUBRICANT
K881338 · KMJ
Upsher-Smith Laboratories, Inc.
General Hospital · 48d
Cleared May 16, 1988
BIOTROL BUN ENZYMATIQUE UV H.P.
K881366 · CDQ
Biotrol, USA, Inc.
Chemistry · 46d
Cleared May 16, 1988
WESBLOT RNP-SM TEST
K881379 · LKP
American Bionetics, Inc.
Immunology · 45d
Cleared May 13, 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
K872541 · LJN
Ortho Diagnostic Systems, Inc.
Microbiology · 319d
Cleared May 13, 1988
ABBOTT CMV-M EIA KIT
K872881 · LKQ
Abbott Laboratories
Microbiology · 296d
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