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
156073–156096 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 1983
DICON GLAUCOMA DIAG. CENTER 2000 SERIES
K832142 · HPT
CooperVision, Inc.
Ophthalmic · 27d
Cleared Aug 01, 1983
SPLINT WOOD
K832144 · ILH
Vermont Wood Industries, Inc.
Physical Medicine · 32d
Cleared Aug 01, 1983
AMBULIZER MODEL MC-5
K832161 · IOR
Mobilizer Medical Products, Inc.
Physical Medicine · 27d
Cleared Jul 29, 1983
VITALINE 2
K822856
American Heartline, Inc.
Cardiovascular · 305d
Cleared Jul 29, 1983
DISPOSABLE MICROTOME BLADES
K831921 · IDL
Polymer Technology Corp.
Pathology · 45d
Cleared Jul 29, 1983
EMBEDDING RING
K831922 · KER
Polymer Technology Corp.
Pathology · 45d
Cleared Jul 29, 1983
LKB 2164 MACRO-SPIN R CENTRIFUGE
K831942 · JQC
Lkb Instruments, Inc.
Chemistry · 43d
Cleared Jul 29, 1983
LKB 2160 MIDISPIN CENTRIFUGE
K831947 · JQC
Lkb Instruments, Inc.
Chemistry · 43d
Cleared Jul 29, 1983
LKB 2161 MIDISPIN R CENTRIFUGE
K831948 · JQC
Lkb Instruments, Inc.
Chemistry · 43d
Cleared Jul 28, 1983
AMBULATORY ECG EVENT RECORDER
K830907 · DSH
Brentwood Instruments, Inc.
Cardiovascular · 129d
Cleared Jul 28, 1983
UNICUFF-BLOOD PRESSURE CUFF
K831001 · DXQ
Frontier Products
Cardiovascular · 121d
Cleared Jul 28, 1983
INTRA-ORAL ARTIFICIAL LARYNX
K831127 · ESE
Xomed, Inc.
Ear, Nose, Throat · 113d
Cleared Jul 28, 1983
LIFESTAT 200
K831232 · DXN
Physio-Control Corp.
Cardiovascular · 104d
Cleared Jul 28, 1983
PRO QUANTUM
K831249 · JQW
Abbott Laboratories
Chemistry · 101d
Cleared Jul 28, 1983
TISSUE-TEK V.I.P. 100/200
K831313 · IEO
Miles Laboratories, Inc.
Pathology · 97d
Cleared Jul 28, 1983
MODEL 947 VIDEO BLOOD GAS SYS
K831379 · CHL
Avl Scientific Corp.
Chemistry · 91d
Cleared Jul 28, 1983
DNA FLOR
K831408 · DHN
Medastat Scientific Corp.
Immunology · 87d
Cleared Jul 28, 1983
SILCATH CENTRAL CATHETER TRAY W/18 GA
K831453 · JCY
Argon Medical Corp.
General & Plastic Surgery · 84d
Cleared Jul 28, 1983
SAVE-A-BAKE PORCELAIN POLISH
K831483 · EIH
Denpac Corp.
Dental · 80d
Cleared Jul 28, 1983
COMPOSI-GLAZE
K831484 · EBF
Denpac Corp.
Dental · 80d
Cleared Jul 28, 1983
KENNEDY TIBIAL COMPONENT
K831513 · HSX
Biomet, Inc.
Orthopedic · 77d
Cleared Jul 28, 1983
SODIUM HYPOCHLORITE 7%
K831619 · PPM
Omega Medical Diagnostics
Hematology · 70d
Cleared Jul 28, 1983
SODIUM HYPOCHLORITE 3%
K831620 · PPM
Omega Medical Diagnostics
Hematology · 70d
Cleared Jul 28, 1983
DIA STRIPS SYSTEM
K831623 · CDM
California Immuno Diagnostic, Inc.
Chemistry · 69d