Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
148081–148104 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 1985
BIO-CHALLENGE TEST PAK
K851804 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 77d
Cleared Jul 16, 1985
THE P.C.A. DOME PATELLA COMPONENT
K852059 · JWH
Howmedica Corp.
Orthopedic · 68d
Cleared Jul 16, 1985
INTRAVENOUS INJECTION SET
K852361 · FPA
The West Co., Inc.
General Hospital · 42d
Cleared Jul 16, 1985
TIMENTIN 85MCG SENSITIVITY DISC
K852423
Difco Laboratories, Inc.
Microbiology · 39d
Cleared Jul 16, 1985
STRYKER 988 ICU BED
K852674 · FNL
Stryker Corp.
General Hospital · 22d
Cleared Jul 15, 1985
EDENTEC MODEL 2000W APNEA MONITOR
K844327 · BZQ
Edentec Corp.
Anesthesiology · 250d
Cleared Jul 15, 1985
MEC DISTAL FEMORAL BOLT
K850403 · KTT
Pfizer, Inc.
Orthopedic · 164d
Cleared Jul 15, 1985
MEC HIP BOLT
K850413 · KTT
Pfizer, Inc.
Orthopedic · 161d
Cleared Jul 15, 1985
MEC ROD CONNECTOR
K850443 · KTT
Pfizer, Inc.
Orthopedic · 160d
Cleared Jul 15, 1985
HOWMEDICA THREADED ACETABULAR COMPONENT
K850840 · KWA
Pfizer, Inc.
Orthopedic · 136d
Cleared Jul 15, 1985
REGIONAL ANESTHESIA TRAYS
K851134 · CAZ
Concord Laboratories, Inc.
Anesthesiology · 116d
Cleared Jul 15, 1985
SYNATOMIC VARIABLE FIT TIBIAL PLATEAU
K851341 · KYK
Depuy, Inc.
Orthopedic · 103d
Cleared Jul 15, 1985
VYGON DELEE SUCTION CATHETER CODE NO 533
K851473 · BSY
Vygon Corp.
Anesthesiology · 91d
Cleared Jul 15, 1985
OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
K851509 · CBK
Ohmeda Medical
Anesthesiology · 91d
Cleared Jul 15, 1985
PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
K851528 · LQM
Pasco Laboratories, Inc.
Microbiology · 88d
Cleared Jul 15, 1985
DART IMMUNOGLOBULINS REAGENT SYSTEM
K851541 · DEW
Coulter Electronics, Inc.
Immunology · 90d
Cleared Jul 15, 1985
TMX-C1/C2 TRADMILL CONTROLLER ACCESS.
K851631 · IOL
Eaton Medical Group
Physical Medicine · 88d
Cleared Jul 15, 1985
EZZIE SYSTEM
K851740 · IQA
Independent Living, Inc.
Physical Medicine · 77d
Cleared Jul 15, 1985
SPINAL FLUID CONTROL
K851820 · JJY
Irvine Scientific
Chemistry · 80d
Cleared Jul 15, 1985
UROLOGICAL CATHETER & ACCESSORIES FOLEY CATHETER
K851857 · KOD
Sheridan Catheter Corp.
Gastroenterology & Urology · 80d
Cleared Jul 15, 1985
OHMEDA GMS ABOSORBER
K852071 · BSF
Ohmeda Medical
Anesthesiology · 63d
Cleared Jul 15, 1985
PHADEBAS RAST TEST ALLERGEN DISCS
K852189 · DHB
Pharmacia, Inc.
Immunology · 56d
Cleared Jul 15, 1985
#3002 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K852311 · CAI
Sigma Medical, Inc.
Anesthesiology · 47d
Cleared Jul 15, 1985
#3005 PEDIATRIC NON-CONDUCT ANES CIR W/ BREA BAG
K852312 · CAI
Sigma Medical, Inc.
Anesthesiology · 47d