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
162457–162480 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1981
DESK ARM WHEELCHAIR ARM EXTENSION
K812348 · KNN
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 11, 1981
HAND SPLINTS & COMPONENTS
K812349 · ILH
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 11, 1981
WHEELCHAIR ACCESSORIES
K812350 · KNO
Fred Sammons, Inc.
Physical Medicine · 24d
Cleared Sep 09, 1981
PLASMA FLEX
K811523 · KSR
Terumo America, Inc.
Chemistry · 103d
Cleared Sep 09, 1981
SPIKE GUARD
K812130 · KDJ
Clinipad Corp.
Gastroenterology & Urology · 44d
Cleared Sep 09, 1981
MEDI VIEW
K812152 · IXC
Medical Synergy
Radiology · 42d
Cleared Sep 09, 1981
LIFE-TECH #1857 PRESSURE/POLOT MODULE
K812177 · EXQ
Life-Tech Instruments, Inc.
Gastroenterology & Urology · 37d
Cleared Sep 09, 1981
ANGIOSCAN SPECTRUM ANALYZER
K812184 · DXK
Unigon Industries, Inc.
Cardiovascular · 37d
Cleared Sep 09, 1981
PLEURAL DRAINAGE SYSTEM #PDS-4300
K812224 · KDQ
Bentley Laboratories, Inc.
General Hospital · 30d
Cleared Sep 09, 1981
GOLD(AU 195) SPOT MARKER SOURCES
K812235 · IXD
Amersham Corp.
Radiology · 29d
Cleared Sep 09, 1981
GOLD(AU 195) GAMMA CAMERA CHECK(FLOOD)
K812236 · IYO
Amersham Corp.
Radiology · 29d
Cleared Sep 09, 1981
HEMOTOLOGY QUALITY CONTROL MIXTURE
K812237 · JPK
American Dade
Hematology · 29d
Cleared Sep 09, 1981
CT/T 9800
K812241 · JAK
General Electric Co.
Radiology · 29d
Cleared Sep 09, 1981
CORDISNHYPERION HEMOGLOBIN A1 TEST SYS
K812242 · LCP
Cordis Corp.
Hematology · 29d
Cleared Sep 09, 1981
HEMATOLOGY CONTROL
K812280 · JPK
American Dade
Hematology · 27d
Cleared Sep 09, 1981
TRYPTICASE SOY BROTH BLOOD CULTURE BOTT
K812335 · JSC
Fisher Scientific Co., LLC
Microbiology · 22d
Cleared Sep 09, 1981
TERUFUSION INFUSION PUMP MODEL STC-502
K812339 · FRN
Terumo Medical Corp.
General Hospital · 22d
Cleared Sep 09, 1981
IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2
K812355 · CAC
Intl. Business Machines
Hematology · 21d
Cleared Sep 09, 1981
PARA 1 SENDAI HEMAGGLUTININ
K812365 · GQR
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Sep 09, 1981
GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD)
K812367 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
RAT BLOOD IN ALSEVER'S, CITRATED
K812368 · LHT
Dutchland Laboratories, Inc.
Microbiology · 20d
Cleared Sep 09, 1981
GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF
K812372 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBR
K812373 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d
Cleared Sep 09, 1981
ADULT CHICKEN BLOOD IN ALSEVER'S, C., D.
K812374 · LHT
Dutchland Laboratories, Inc.
Immunology · 20d