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
143113–143136 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 1986
R1618, R1619 & R1654 ICE MAKING MACHINES
K861343
Tri W-G, Inc.
Physical Medicine · 101d
Cleared Jul 17, 1986
DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET
K861390 · FMI
Baxter Healthcare Corp
General Hospital · 94d
Cleared Jul 17, 1986
DISPOSABLE STOPCOCK
K861783 · DTL
Utah Medical Products, Inc.
Cardiovascular · 70d
Cleared Jul 17, 1986
FUTUREMED ECG SYSTEM 500
K862381 · DPS
Futuremed Div. of Future Impex Corp.
Cardiovascular · 23d
Cleared Jul 17, 1986
HALL STERNUM SAW
K862474 · DWH
Hall Surgical, Division of Zimmer, Inc.
General & Plastic Surgery · 17d
Cleared Jul 17, 1986
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1
K862510 · KRI
Shiley, Inc.
Cardiovascular · 16d
Cleared Jul 17, 1986
DISPENS-O-DISC DIFFERENTIATION DISKS PYR
K862570 · JTO
Difco Laboratories, Inc.
Microbiology · 10d
Cleared Jul 17, 1986
SURGICAL LASER ACCESSORIES (SLA) CASE
K862629 · FSM
Simpson/Basye, Inc.
General & Plastic Surgery · 7d
Cleared Jul 16, 1986
GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM
K860498 · LQH
Gen-Probe, Inc.
Microbiology · 156d
Cleared Jul 16, 1986
ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
K860585 · DXY
Cardiac Pacemakers, Inc.
Cardiovascular · 148d
Cleared Jul 16, 1986
ANGIOMEDICS CATH SHEATH INTRODUC W/HEMOSTASIS VALV
K861238 · DYB
Angiomedics, Inc.
Cardiovascular · 105d
Cleared Jul 16, 1986
MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT
K861379 · LKT
Serono Diagnostics, Inc.
Microbiology · 93d
Cleared Jul 16, 1986
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · DWB
Shiley, Inc.
Cardiovascular · 72d
Cleared Jul 16, 1986
SIEMENS RADIOTHERM 706, MICROWAVE THERAPY UNIT
K862029 · IOA
Elmed, Inc.
Physical Medicine · 49d
Cleared Jul 16, 1986
IN SITU EAR GAIN AUDIO TEST STAT TYPE 2118/WH 1823
K862086 · ETW
A/S Bruel & Kjaer
Ear, Nose, Throat · 44d
Cleared Jul 16, 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
K862116 · DWB
Shiley, Inc.
Cardiovascular · 43d
Cleared Jul 16, 1986
IMTECH FIXATION SYSTEMS
K862139 · JEY
Imtech, Inc.
Dental · 42d
Cleared Jul 16, 1986
MICRODILUTION PANELS
K862140 · JWY
American Micro Scan
Microbiology · 42d
Cleared Jul 16, 1986
INEARSET IES HEARING AID
K862222 · ESD
Inearset, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 16, 1986
POROUS COATED HIP FEMORAL PROSTHESIS
K862326 · LPH
Johnson & Johnson Professionals, Inc.
Orthopedic · 27d
Cleared Jul 16, 1986
SURGICAL DRAPES AND DRAPE ACCESSORIES
K862438 · KKX
Avery Intl.
General Hospital · 20d
Cleared Jul 16, 1986
LYNX EL MICROSCOPY TISSUE PROCESSOR
K862457 · IDZ
Australian Biomedical Corporation , Ltd.
Pathology · 16d
Cleared Jul 16, 1986
MS-179 ELECTRONIC MUSCLE STIMULATOR
K862485 · IPF
Electro Med Supply, Inc.
Physical Medicine · 16d
Cleared Jul 16, 1986
MS-159 ELECTRONIC MUSCLE STIMULATOR
K862486 · IPF
Electro Med Supply, Inc.
Physical Medicine · 16d