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
161905–161928 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 1982
SIEMENS POLYDOROS 800
K827064
Siemens Medical Solutions USA, Inc.
Radiology · 40d
Cleared Feb 24, 1982
LATERAL ANGULATING FLUORO SUSPENSION
K827086
General Electric Co.
Radiology · 33d
Cleared Feb 23, 1982
DADE FACTOR ASSAY REFERENCE PLASMA
K820085 · GGP
American Dade
Hematology · 42d
Cleared Feb 23, 1982
TRACH TAPE
K820099 · BTO
Stan-Pak Ent.
Anesthesiology · 41d
Cleared Feb 23, 1982
NUPRO* GEL TRAY
K820104 · KMT
Johnson & Johnson Professionals, Inc.
Dental · 39d
Cleared Feb 23, 1982
BOUNDARY
K820116 · FYA
The Buckeye Cellulose Corp.
General Hospital · 36d
Cleared Feb 23, 1982
MODEL 343 HEARING AID
K820148 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 35d
Cleared Feb 23, 1982
EMIT FREELEVEL SYSTEM I
K820224 · JRL
Syva Co.
Chemistry · 27d
Cleared Feb 23, 1982
STER-O-DOSE
K820227 · CAF
Inhalation Therapy Equipment, Co.
Anesthesiology · 27d
Cleared Feb 23, 1982
DIGOXIN RADIOIMMUNOASSAY
K820274 · DPB
American Diagnostic Corp.
Toxicology · 21d
Cleared Feb 23, 1982
MICRO-AIRE REPLACEMENT DRILL BURS
K820281 · GFF
Micro-Aire Surgical Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Feb 23, 1982
SIGMA 2000 GAS CHROMATOGRAPH
K820283 · KZQ
The Perkin-Elmer Corp.
Toxicology · 21d
Cleared Feb 23, 1982
SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL
K820286 · LAS
Syva Co.
Toxicology · 21d
Cleared Feb 23, 1982
EMIT AND NETILMICIN CONTROL
K820323 · LAS
Syva Co.
Toxicology · 18d
Cleared Feb 23, 1982
EMIT AND NETILMICIN ASSAY
K820324 · LCE
Syva Co.
Toxicology · 18d
Cleared Feb 23, 1982
IMPACT, MODEL E-12
K820330 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 15d
Cleared Feb 23, 1982
IMPACT, MODEL 302
K820331 · JCX
Impact Instrumentation, Inc.
General & Plastic Surgery · 15d
Cleared Feb 23, 1982
NEEDLE & BLADE COUNTER
K820332 · FSM
Abco Dist.
General & Plastic Surgery · 15d
Cleared Feb 23, 1982
ISLAM BONE MARROW BIOPSY NEEDLE
K820339 · GDM
Downs Surgical , Ltd.
General & Plastic Surgery · 15d
Cleared Feb 22, 1982
HEMOTOLOGY CALIBRATOR
K813530 · KSA
American Dade
Hematology · 67d
Cleared Feb 22, 1982
MODEL 3000C CALORIC IRRIGATOR
K813552 · ETP
Life-Tech Intl., Inc.
Ear, Nose, Throat · 63d
Cleared Feb 22, 1982
CARDIO-BAND
K813566 · LDQ
Cardio-Band, Inc.
General & Plastic Surgery · 62d
Cleared Feb 22, 1982
INTELECT MODEL 200
K813593 · IMI
Chattanooga Group, Inc.
Physical Medicine · 87d
Cleared Feb 22, 1982
INTELECT MODEL 700
K813594 · IMG
Chattanooga Group, Inc.
Physical Medicine · 87d