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
133753–133776 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 30, 1988
CHECK-MM
K883223 · JHS
Intl. Immunoassay Laboratories, Inc.
Chemistry · 63d
Cleared Sep 30, 1988
RAPIDTEST-HCG (TM)
K883235 · DHA
Synbiotics Corp.
Chemistry · 60d
Cleared Sep 30, 1988
MULTI-CARE CHAIR
K883309 · INM
Mid-Canada Medical
Physical Medicine · 56d
Cleared Sep 30, 1988
AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT
K883522 · LBK
Amerimed US Corp.
Neurology · 44d
Cleared Sep 30, 1988
HORIZON ORTHOPEDIC PIN PROTECTOR
K883576 · LYT
Horizon Medical, Inc.
Orthopedic · 39d
Cleared Sep 30, 1988
#400 BROOK AIRWAY & #900 PROFESSIONAL BROOK AIRWAY
K883593 · CAE
Ecolab, Inc.
Anesthesiology · 38d
Cleared Sep 30, 1988
PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER
K883607 · GYK
Codman & Shurtleff, Inc.
Neurology · 38d
Cleared Sep 30, 1988
ATS BLOOD RECOVERY BAG
K883663 · CAC
Atrium Medical Corp.
Anesthesiology · 35d
Cleared Sep 30, 1988
DAS SPORT PUMP(TM)
K883681 · ILO
D.A. Schulman, Inc.
Physical Medicine · 32d
Cleared Sep 30, 1988
RESUSCITATION BAG EXHALATION FILTER
K883693 · CAH
Intertech Resources, Inc.
General Hospital · 32d
Cleared Sep 30, 1988
DERMTRODE
K883869 · GYA
World Precision Instruments, Inc.
Neurology · 17d
Cleared Sep 30, 1988
MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)
K883951 · KIT
J R Scientific
Pathology · 11d
Cleared Sep 30, 1988
HARE COLD PACK
K883966 · IMD
Dyna Industries, Inc.
Physical Medicine · 10d
Cleared Sep 29, 1988
SAFE-STRIPS
K880548 · JOJ
Medstar, Inc.
General Hospital · 233d