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
169417–169440 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 17, 1979
BARD URODYNAMIC CATHETERS
K791717 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 17d
Cleared Sep 12, 1979
VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.
K770428 · FSM
Holco Instrument Corp.
General & Plastic Surgery · 919d
Cleared Sep 12, 1979
ANTISERUM TO RABBIT IGG H & L CHAIN
K790706 · DFH
Kent Laboratories, Inc.
Immunology · 153d
Cleared Sep 12, 1979
ELECTROENCEPHALOGRAPHS MODELS 7209,7213
K791150 · GWQ
Nihon Kohden America, Inc.
Neurology · 89d
Cleared Sep 12, 1979
MODEL EEG-4214 ELECTROENCEPHALOGRAPH
K791233 · GWQ
Nihon Kohden America, Inc.
Neurology · 75d
Cleared Sep 12, 1979
MODEL EEG-4217 ELECTROENCEPHALOGRAPH
K791234 · GWQ
Nihon Kohden America, Inc.
Neurology · 75d
Cleared Sep 12, 1979
MIRADAPT* DENTAL RESTORATIVE
K791318 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 62d
Cleared Sep 12, 1979
MIRADAPT* POLISHING INSTRUMENTS
K791319 · EJR
Johnson & Johnson Professionals, Inc.
Dental · 62d
Cleared Sep 12, 1979
JELCO & KVO CATHETER PLACEMENT UNIT
K791372 · JCY
Jelco Laboratories
General & Plastic Surgery · 50d
Cleared Sep 12, 1979
MODEL 484-01 BIPOLAR COAXIAL PACING LEAD
K791377 · DTB
Intermedics, Inc.
Cardiovascular · 50d
Cleared Sep 12, 1979
MODEL 482-01 BIPOLAR COAXIAL PACING LEAD
K791378 · DTB
Intermedics, Inc.
Cardiovascular · 50d
Cleared Sep 12, 1979
MODEL 228-02 THINLITH II PACEMAKER, BIPO
K791379 · DXY
Intermedics, Inc.
Cardiovascular · 50d
Cleared Sep 12, 1979
FLEXIFO ENTERAL NUTRITION PUMP
K791528 · FRN
Abbott Laboratories
General Hospital · 33d
Cleared Sep 12, 1979
FLEXIFLO ENTERAL PUMP SET
K791531 · BSS
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Sep 12, 1979
TEMP-STIK MODEL #300
K791558 · FLL
Temp-Stik Corp.
General Hospital · 26d
Cleared Sep 12, 1979
MODIFIED TEMPA-DOT THERMOMETER
K791574 · FQZ
Info-Chem
General Hospital · 30d
Cleared Sep 12, 1979
TENS-O-TEST
K791637 · DXN
Curomatic, Inc.
Cardiovascular · 22d
Cleared Sep 12, 1979
MODEL E2510 SURGISWITCH
K791638 · GEI
Valleylab, Inc.
General & Plastic Surgery · 22d
Cleared Sep 12, 1979
MODEL E2515 ELECTROSURGICAL ACCESSORY
K791639 · GEI
Valleylab, Inc.
General & Plastic Surgery · 22d
Cleared Sep 12, 1979
BONE MARROW NEEDLE
K791643 · GDM
Johannah Medical Services, Inc.
General & Plastic Surgery · 20d
Cleared Sep 12, 1979
PREPACELL-BONE MARROW SAMPLER
K791660 · FMF
Applied Medical Devices, Inc.
General Hospital · 22d
Cleared Sep 12, 1979
CARDIOVASCULAR INSTRUMENTS-VARIOUS
K791710 · DWS
Edward Weck, Inc.
Cardiovascular · 16d
Cleared Sep 12, 1979
SURGICAL INSTRUMENTS HEIFETZ DIGITATE
K791734 · FZT
Edward Weck, Inc.
General & Plastic Surgery · 12d
Cleared Sep 07, 1979
URITRON URINE METER
K790894 · FFG
Joseph F. Daniel, C.R.N.A.
Gastroenterology & Urology · 122d