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
146977–147000 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 16, 1985
FLEXIROOT
K852305 · DZE
Facial Alveodental Implant...
Dental · 140d
Cleared Oct 16, 1985
DOWNS VPAP CIRCUIT
K852333 · CAN
Vital Signs, Inc.
Anesthesiology · 138d
Cleared Oct 16, 1985
PHARMA-PLAST CLINIPAK
K852443 · FMF
Pharma-Plast USA, Inc.
General Hospital · 128d
Cleared Oct 16, 1985
ASIK 'ONCE' SYRINGE
K852444 · FMF
Pharma-Plast USA, Inc.
General Hospital · 128d
Cleared Oct 16, 1985
DOUBLE PUNCTURE INSTRUMENTS
K852901 · HET
L.A.S.E.R., Inc.
Obstetrics & Gynecology · 99d
Cleared Oct 16, 1985
KNEE MACHINE
K852977 · BXB
Kaiser Medical
Physical Medicine · 93d
Cleared Oct 16, 1985
MEDNOVA SAFETY BAG
K853075 · LHI
Mednova Corp.
General Hospital · 85d
Cleared Oct 16, 1985
STORZ SOLID-STANDOFF PACHYMETRY PROBE
K853087 · IYO
Storz Instrument Co.
Radiology · 85d
Cleared Oct 16, 1985
COOPER LASER SONICS CUSA MODEL 200
K853143 · LBK
Cooper Lasersonics, Inc.
Neurology · 79d
Cleared Oct 16, 1985
CARD THREE IM TEST ITEM #2035, CARD ONE IM #2036
K853144 · KTN
Preco, Inc.
Immunology · 79d
Cleared Oct 16, 1985
BOEHRINGER LAB SUCTION INTERRUPTER
K853155 · KDP
Boehringer Laboratories
General Hospital · 79d
Cleared Oct 16, 1985
ENDODONTIC ELECTRONIC SPREADER HEATER
K853183 · EKK
Sturgeon Engineering Co.
Dental · 78d
Cleared Oct 16, 1985
TRACOR MODEL RA600 MICROPROCESSOR AUDIOMETER
K853245 · EWO
Tracor Instruments, Inc.
Ear, Nose, Throat · 76d
Cleared Oct 16, 1985
J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO
K853251 · DTZ
Johnson & Johnson Professionals, Inc.
Cardiovascular · 79d
Cleared Oct 16, 1985
H-H HUNTER PASSIVE TENDON IMPLANT
K853436 · HXR
Holter-Hausner Intl.
General & Plastic Surgery · 62d
Cleared Oct 16, 1985
H-H HUNTER TENDON ROD
K853437
Holter-Hausner Intl.
Orthopedic · 62d
Cleared Oct 16, 1985
POLYCARB WATER SET
K853447 · EMA
Pulpdent Corp. of America
Dental · 61d
Cleared Oct 16, 1985
PEE WEE THERMOMETERS
K853515 · FQZ
Joel R.L. Ehren Kranz
General Hospital · 55d
Cleared Oct 16, 1985
OXYGEN MONITOR OM-100 & OXYGEN PROBE OP-100
K853786 · CCE
American Bentley
Anesthesiology · 36d
Cleared Oct 16, 1985
NEOGUARD REFLECTOR
K853794 · FMT
Cas Medical Systems, Inc.
General Hospital · 35d
Cleared Oct 16, 1985
SURGICAL TAPES CLOTH, PAPER & PLASTIC-BASE
K853820 · KGX
Abco Dealers, Inc.
General & Plastic Surgery · 34d
Cleared Oct 16, 1985
LH/FSH RADIOIMMUNOASSAY KIT
K853837 · CEP
Bioclinical Group
Chemistry · 30d
Cleared Oct 16, 1985
JMS LCC INSULIN SYRINGE
K853838 · FMF
Jms Co., Ltd.
General Hospital · 72d
Cleared Oct 16, 1985
V-TREND ASO PLUS LATEX TEST
K853857 · GTQ
Texas Immunology, Inc.
Microbiology · 30d