FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
167785–167808 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 10, 1979
DEXIDE DISPOSABLE SURGICAL SCRUB SPONGE
K792271 · GEC
Dexide, Inc.
General & Plastic Surgery · 27d
Cleared Dec 10, 1979
DEXIDE DIS. PREP SPONGE W/IDEX PATIENT P
K792273 · GEC
Dexide, Inc.
General & Plastic Surgery · 27d
Cleared Dec 10, 1979
PENTAX FLEXIBLE SIGMOIDOSCOPE MOD. FS-34
K792341 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 21d
Cleared Dec 10, 1979
BIPOLAR FORCEPS
K792365 · JOS
Concept, Inc.
General & Plastic Surgery · 17d
Cleared Dec 10, 1979
HYPERALIMENTATION DRESSING TRAY
K792369 · FRG
Pharmaseal Div., Baxter Healthcare Corp.
General Hospital · 77d
Cleared Dec 10, 1979
BONGORT ODOR BARRIER DRAIN
K792381 · EXB
Howmedica Corp.
Gastroenterology & Urology · 14d
Cleared Dec 10, 1979
NUTRA-PH INSTRUMENT MILK
K792386
Hospital Products Co.
General & Plastic Surgery · 14d
Cleared Dec 07, 1979
SCI MED PERICARDIAL SUBSTITUTE
K791792 · DXZ
Scimed Life Systems, Inc.
Cardiovascular · 85d
Cleared Dec 07, 1979
AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER
K792020 · DRS
Life Medical Services, Inc.
Cardiovascular · 59d
Cleared Dec 07, 1979
INTEGRAL DISPOSABLE HOLDER CARPENTIER
K792034 · DTJ
Edwards Laboratories
Cardiovascular · 58d
Cleared Dec 07, 1979
COAGULASE PLASMA
K792235 · JTL
Remel Co.
Microbiology · 31d
Cleared Dec 07, 1979
CHOL-HDL TEST, HIGH LIPO. CHOL TEST
K792313 · LBR
Sclavo, Inc.
Chemistry · 21d
Cleared Dec 07, 1979
ELVI CREATININE
K792397 · CGX
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI GLUCOSE
K792398 · CGA
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI MAGNESIUM
K792399 · JGJ
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI CHLORIDE
K792400 · CHJ
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI INORGANIC PHOSPHOROUS
K792401 · CEO
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI CREATININ
K792402 · CGX
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI URIC ACID-COLORIMETRIC METHOD
K792403 · CDH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI CREATININE
K792404 · CGX
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI ACID & PROSTATIC PHOSPHATASE
K792405 · JFH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI SERUM IRON
K792406 · CFM
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI URIC ACID
K792412 · CDH
Volu Sol Medical Industries
Chemistry · 11d
Cleared Dec 07, 1979
ELVI ALKALINE PHOSPHATATASE
K792413 · CJE
Volu Sol Medical Industries
Chemistry · 11d