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
155929–155952 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1983
LYSING & HEMOGLOBIN S-REAGENT J & S
K833444 · GGK
Jasins & Sayles Associates, Inc.
Hematology · 29d
Cleared Nov 02, 1983
PECOR 8.5 FRENCH IAB ON A DATASCOPE
K831307 · DSP
Datascope Corp.
Cardiovascular · 194d
Cleared Nov 02, 1983
FRENCH INTRA-AORTIC 9.5 BALLOON ON KON
K831397 · DSP
Datascope Corp.
Cardiovascular · 187d
Cleared Oct 31, 1983
WEIL PERFUSOMETER #100
K830429 · FLL
Wescor, Inc.
General Hospital · 264d
Cleared Oct 31, 1983
GLUCOKEY
K831194 · CGA
Ulster Scientific, Inc.
Hematology · 202d
Cleared Oct 31, 1983
LASTOBAND ADHESIVE BANDAGES
K831454 · NAD
Smith & Nephew, Inc.
General & Plastic Surgery · 178d
Cleared Oct 31, 1983
CAPNOGRAPH
K831776 · CCK
Datascope Corp.
Anesthesiology · 151d
Cleared Oct 31, 1983
PATIENT MONITOR #RM-100
K831817 · DRT
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
CENTRAL STATION MONITOR CSM-100
K831818 · DRT
Honeywell, Inc.
Cardiovascular · 147d
Cleared Oct 31, 1983
ROUND-BEEHIVE- DISSECTORS 3/8
K831912 · GDI
Ormed Mfg., Inc.
General & Plastic Surgery · 139d
Cleared Oct 31, 1983
STRUNG NEURO SPONGE PATTIES-X-RAY-
K831914 · GDY
Ormed Mfg., Inc.
General & Plastic Surgery · 139d
Cleared Oct 31, 1983
MEDICAL ELECTRONICS-PRINTER CLOCK
K832012 · DSF
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
LME PATIENT MONITOR SMS 151
K832013 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
MULTISCRIPTOR EK #403 VARIOUS MODEL
K832014 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
MULTISCRIPTOR EK VARIOUS #43
K832015 · DPS
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
LME BLOOD PRESSURE MONITOR
K832017 · DSK
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
SERVOMED COMPACT MONITOR 181/10105002
K832018 · DRT
Litton Medical Electronics
Cardiovascular · 130d
Cleared Oct 31, 1983
SCD SKIN TEMP. SENSORS #3400 ETC
K832090 · FLL
Science Development Corp.
General Hospital · 125d
Cleared Oct 31, 1983
MULTISCRIPTOR EK 36/101 047 02,05
K832130 · DPS
Litton Medical Electronics
Cardiovascular · 122d
Cleared Oct 31, 1983
SIMPLISCRIPTOR EK 31/101 037 16
K832184 · DPS
Litton Medical Electronics
Cardiovascular · 117d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN IMMUNOGLOBULINS-
K832256 · DFH
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC
K832258 · DEW
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
GOAT ANTI-HUMAN KAPPA AFFINITY
K832260 · DEO
Gelco Diagnostics, Inc.
Immunology · 123d
Cleared Oct 31, 1983
FITC GOAT ANTI-HUMAN IMMUNOGLOBULINS
K832262 · CZN
Gelco Diagnostics, Inc.
Immunology · 123d