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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
165289–165312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1981
AUTOMATED PERIMETERS
K803159 · HPT
Coburn Optical Ind., Inc.
Ophthalmic · 58d
Cleared Feb 04, 1981
FISHER-PICKERING INTRAOCULAR EYE MAGNET
K803194 · HNR
Storz Instrument Co.
Ophthalmic · 50d
Cleared Feb 04, 1981
SYSTEM 1 INSTRUMENT STAND
K803195 · HMF
Surgical Mechanical Research, Inc.
Ophthalmic · 50d
Cleared Feb 04, 1981
GEO-TIBIAL RETAINER ROTATIONAL
K803235 · HSX
Zimmer, Inc.
Orthopedic · 44d
Cleared Feb 04, 1981
LL100 CRYOSURGICAL SYSTEM
K803311 · GEH
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 33d
Cleared Feb 04, 1981
MICROMEDIC AUTOMATIC COMPUTING CENTER
K803312 · JQP
Micomedic Systems
Radiology · 33d
Cleared Feb 04, 1981
AUTOCLIX
K810075 · FMK
Biodynamics Corp.
General & Plastic Surgery · 22d
Cleared Feb 04, 1981
CELLONA PLASTER VARNISH
K810111 · ITG
Secol Co.
Physical Medicine · 19d
Cleared Feb 04, 1981
SWR DISPOSABLE PREP RAZOR
K810112 · KDC
G.D. Searle and Co.
General & Plastic Surgery · 19d
Cleared Feb 04, 1981
ISOROBIC SKINFOLD CALIPER
K810116 · KTZ
Fitness Motivation Institute of America
Orthopedic · 20d
Cleared Feb 04, 1981
REINFORCED HIP CUP
K810120 · JDI
Biomet, Inc.
Orthopedic · 19d
Cleared Feb 04, 1981
SWAN-GANZ VIP THERMODILUTION CATHETER
K810124 · DYG
American Edwards Laboratories
Cardiovascular · 16d
Cleared Feb 04, 1981
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
K810162 · DXC
American Edwards Laboratories
Cardiovascular · 13d
Cleared Feb 04, 1981
LAPAROTOMY SPONGE
K810184 · GDY
Medical Action Industries, Inc.
General & Plastic Surgery · 13d
Cleared Feb 04, 1981
MICROMEDIC SYSTEMS' AUTOPAK
K810186 · CGN
Micromedic Systems
Chemistry · 13d
Cleared Feb 04, 1981
TOXICOLOGY CONTROL
K810201 · LAS
Utak Laboratories, Inc.
Toxicology · 12d
Cleared Feb 04, 1981
POWERED PATIENT SYSTEM
K810220 · IKZ
Tri W-G, Inc.
Physical Medicine · 8d
Cleared Feb 04, 1981
LIMB ORHTOSIS
K810222 · ITQ
Medical Design & Manufacturing Corp.
Physical Medicine · 8d
Cleared Feb 02, 1981
ISO-BAC INSTRUMENT WRAP
K802919 · FRG
American Convertors Div., American...
General Hospital · 76d
Cleared Feb 02, 1981
TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300
K802978 · KLK
Brattle Instrument Corp.
Anesthesiology · 73d
Cleared Feb 02, 1981
ALGINATE/SILICONE CROWN & BRIDGE MATER
K802990 · ELW
Buffalo Dental Mfg. Co., Inc.
Dental · 70d
Cleared Feb 02, 1981
IONESCU-SHILEY AORTIC GRAFT VALVE
K803000 · DSY
Shiley, Inc.
Cardiovascular · 69d
Cleared Feb 02, 1981
AUTO-MATE CAMERA
K803157 · IYO
Aptek , Ltd.
Radiology · 60d
Cleared Feb 02, 1981
COMPRESSED AIR & OXYGEN GEN./DELIVERY SY
K803232 · CAW
Dri-Aire, Inc.
Anesthesiology · 42d