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
134329–134352 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 03, 1988
FEMALE CONTINENCE DEVICE
K883721 · HHW
Cook Ob/Gyn
Obstetrics & Gynecology · 33d
Cleared Oct 03, 1988
QTEST PREGNANCY TEST CONTROL
K883741 · JJX
Quidel Corp.
Chemistry · 32d
Cleared Oct 03, 1988
CONE MASKS, VARIOUS TYPES OF SURGICAL CONE MASKS
K883828 · FXX
Greene International Corp.
General Hospital · 24d
Cleared Oct 03, 1988
TANNING BED
K883929 · FTC
Dallas Tan, Inc.
General & Plastic Surgery · 18d
Cleared Sep 30, 1988
COLORECTAL CANCER RISK DETECTOR (TM)
K874180 · KHE
Pearce Clinical Laboratories, Inc.
Hematology · 352d
Cleared Sep 30, 1988
TOXOPLASMA GONDII IGG ELISA KIT
K875258 · LGD
De Ferris Laboratories, Inc.
Microbiology · 283d
Cleared Sep 30, 1988
LOTA, LIFECARE OXYGEN/TEMPERATURE ANALYZER 36-001
K880378 · CCL
Lifecare Services, Inc.
Anesthesiology · 247d
Cleared Sep 30, 1988
MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD
K881177 · GWL
Nihon Kohden America, Inc.
Neurology · 196d
Cleared Sep 30, 1988
CBC/CONSTAVAC BLOOD CONSERVATION SYSTEM
K881350 · CAC
Stryker Corp.
Anesthesiology · 184d
Cleared Sep 30, 1988
REP GLYCO SYSTEM
K881863 · LCP
Helena Laboratories
Hematology · 150d
Cleared Sep 30, 1988
HEPAX (TENS)
K882154 · GZJ
Avl Scientific Corp.
Neurology · 130d
Cleared Sep 30, 1988
URISCREEN
K882211 · JXA
Diatech Diagnostica , Ltd.
Microbiology · 127d
Cleared Sep 30, 1988
STERILE INHALATION WATER TRANSFER SET
K882582 · BTT
Intertech Resources, Inc.
Anesthesiology · 100d
Cleared Sep 30, 1988
BEAR EVC-100 CONTROLLER
K882764 · CBK
Bear Medical Systems, Inc.
Anesthesiology · 86d
Cleared Sep 30, 1988
HELENA COLOCARE
K882799 · KHE
Helena Laboratories
Hematology · 86d
Cleared Sep 30, 1988
JMS CERVICAL TRACTION DEVICE/HALO DEVICE
K882877 · JEC
Jerome Medical
Orthopedic · 81d
Cleared Sep 30, 1988
MULTIDAY, MODELS 8300 AND 8310
K882888 · GXY
Medical Devices, Inc.
Neurology · 81d
Cleared Sep 30, 1988
SLT CL60 CONTACT LASER SYSTEM, CUTTING & COAGULA.
K882908 · HQF
Surgical Laser Technologies, Inc.
Ophthalmic · 80d
Cleared Sep 30, 1988
BONE FIXATION WIRE
K882967 · JDQ
Baxter Healthcare Corp
Orthopedic · 77d
Cleared Sep 30, 1988
MODIFIED SL-SERIES LINEAR ACCELERATORS
K883067 · IYE
Philips Medical Systems, Inc.
Radiology · 116d
Cleared Sep 30, 1988
ON THE SPOT CANDIDASURE
K883118 · LRF
Medi-Tech, Inc.
Microbiology · 67d
Cleared Sep 30, 1988
AMERLITE FREE THYROID CONTROL SERA LAN.4002
K883124 · JJY
Amersham Corp.
Chemistry · 66d
Cleared Sep 30, 1988
MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLY
K883127 · KHX
Advanced Mechanical Technology, Inc.
Physical Medicine · 66d
Cleared Sep 30, 1988
ISOFOR-MM (TM)
K883222 · JHW
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d