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

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175,820 results
144193–144216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1986
COLIN ELECTRONICS CO., LTD. STBP 680
K854481 · DXN
Colin Medical Instruments Corp.
Cardiovascular · 214d
Cleared Jun 09, 1986
70 ML RESERVOIR BAG AND ADMINISTRATION SETS
K860222 · FRN
Prn Services, Inc.
General Hospital · 138d
Cleared Jun 09, 1986
LENS SPECTACLE NON-CUSTOM (PRESCRIPTION)
K861162 · HQG
Efop
Ophthalmic · 73d
Cleared Jun 09, 1986
SUCTION SYSTEM
K861306 · GEA
Axiom Medical, Inc.
General & Plastic Surgery · 62d
Cleared Jun 09, 1986
PATIENTCARE 1000
K861324 · FRN
Criticare Technologies Corp.
General Hospital · 62d
Cleared Jun 09, 1986
SOF SET, MODELS 111 AND 112
K861436 · FRN
Pacesetter Systems
General Hospital · 53d
Cleared Jun 09, 1986
MULTILUMEN VIAPIC CENTRAL LINE CATHETER
K861510 · FOZ
Warner-Lambert Co.
General Hospital · 47d
Cleared Jun 09, 1986
SCHNEIDER-SHILEY WIRE TORQUER
K861606 · DQX
Shiley, Inc.
Cardiovascular · 41d
Cleared Jun 09, 1986
SCHNEIDER-SHILEY INFLATION SYRINGES
K861607 · MAV
Shiley, Inc.
Cardiovascular · 41d
Cleared Jun 09, 1986
SEIKO P-2 & SEIKO P-3 (SPECTACLE LENS)
K861684 · HQG
Seiko Optical Products of America, Inc.
Ophthalmic · 38d
Cleared Jun 09, 1986
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
K861723 · KWA
Osteonics Corp.
Orthopedic · 34d
Cleared Jun 09, 1986
TEC PORTAMAX H.V. PULSED GALVANIC STIMULATOR
K861739 · IPF
J.A. Preston Corp.
Physical Medicine · 34d
Cleared Jun 09, 1986
SAPPHIRE KNIFE BLADE
K861744 · HNN
Keeler Instruments, Inc.
Ophthalmic · 34d
Cleared Jun 09, 1986
GIRARD SUNGLASSES (NON-PRESCRIPTION)
K861759 · HQG
H. Girard S.A.
Ophthalmic · 34d
Cleared Jun 09, 1986
CORNEAL TRANSPLANT TREPHINE DISPOSABLE BLADE
K861825 · HRH
Storz Instrument Co.
Ophthalmic · 28d
Cleared Jun 09, 1986
POLYPOLE
K861838 · FOX
Poly Medical Technologies, Inc.
General Hospital · 27d
Cleared Jun 09, 1986
PHONIC EAR
K861857 · ETW
Phonic Ear, Inc.
Ear, Nose, Throat · 26d
Cleared Jun 09, 1986
KOTEX PROFILE SHAPED MAXI PAD
K861902 · HHD
Kimberly-Clark Corp.
Obstetrics & Gynecology · 24d
Cleared Jun 09, 1986
STERILE O. R. TOWEL
K861928 · IXX
Anago, Inc.
Radiology · 20d
Cleared Jun 09, 1986
SALIVA EJECTOR
K861934 · DYN
Carlisle Laboratories, Inc.
Dental · 20d
Cleared Jun 09, 1986
ZIMLITE LENS
K861960 · HQG
Asahi Optical Co. C/O Rosati...
Ophthalmic · 20d
Cleared Jun 09, 1986
UNITEK CERAMIC BRACKET SYSTEM
K861965 · DYW
Unitek Corp.
Dental · 21d
Cleared Jun 09, 1986
MODIFICATION OF SUNTANA SUN SYSTEM BED
K861989 · FTC
Hawaiian Tan Spa
General & Plastic Surgery · 17d
Cleared Jun 09, 1986
MODEL 43200A CARDIAC MONITOR
K861992 · DPS
Hewlett-Packard Co.
Cardiovascular · 17d