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
139561–139584 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1987
SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA)
K871811 · CIC
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC ANTERIOR TORSO-ARM SUPPORT
K871820 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC POSTERIOR BODY SUPPORT
K871821 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC U-HOOK ASSEMBLY
K871822 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC TIBIAL POSITIONER
K871823 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC SUSPENSION SYSTEM
K871824 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 15d
Cleared May 26, 1987
BIOMEK 1000C AUTOMATED LABORATORY WORK STATION
K871838 · JJG
Beckman Instruments, Inc.
Chemistry · 14d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC PELVIC CALIPER SUPPORT
K871839 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 14d
Cleared May 26, 1987
MCCONNELL ORTHOPEDIC ANKLE POSITIONER
K871840 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 14d
Cleared May 26, 1987
SORBITOL MACCONKEY (SMAC) AGAR, DRI & PRE-FORM
K871855 · JSH
Gibco Laboratories Life Technologies,...
Microbiology · 13d
Cleared May 26, 1987
CIBA CORNING MAGIC LITE ANALYZER II
K871874 · JJQ
Ciba Corning Diagnostics Corp.
Chemistry · 12d
Cleared May 22, 1987
LUXTEC FIBEROPTIC CABLES
K864387 · EQH
Luxtec Corp.
Ear, Nose, Throat · 198d
Cleared May 22, 1987
CUI TISSUE EXPANDER VERSAFIL(TM) TISSUE EXPANDER
K865056 · LCJ
Cox-Uphuff Intl.
General & Plastic Surgery · 149d
Cleared May 22, 1987
TDMAC-HEPARIN COATED RMI
K870421 · DWF
Research Medical, Inc.
Cardiovascular · 108d
Cleared May 22, 1987
MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC
K870839 · HQF
Directed Energy, Inc.
Ophthalmic · 86d
Cleared May 22, 1987
GESCO ASPIRATOR
K870962 · BSY
Gesco Intl., Inc.
Anesthesiology · 73d
Cleared May 22, 1987
RADIOPAQUE SPHERICAL EMBOLI (RSE)
K871047 · HCG
Interventional Therapeutics Corp.
Neurology · 66d
Cleared May 22, 1987
OLYMPIC SMART SCALE
K871104 · FRW
Olympic Medical Corp.
General Hospital · 64d
Cleared May 22, 1987
KRONNER UNIVERSAL FRAME EXTERNAL FIXATION
K871247 · KTT
Kronner Medical
Orthopedic · 53d
Cleared May 22, 1987
KRONNER BI-PLANER TIBIA EXTERNAL FIXATION
K871249 · KTT
Kronner Medical
Orthopedic · 53d
Cleared May 22, 1987
CIRCAMED FULL DISCLOSURE SYSTEM
K871251 · DSI
Circadian, Inc.
Cardiovascular · 53d
Cleared May 22, 1987
APEX SUCTION CURETTE
K871384 · GEA
Apex Medical, Inc.
General & Plastic Surgery · 45d
Cleared May 22, 1987
ACS ENHANCED-TORQUE CORONARY GUIDING CATHETER
K871425 · DQY
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 44d
Cleared May 22, 1987
VIDEOSCAN (TM)
K871479 · HLQ
Kera Corp.
Ophthalmic · 38d