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
158449–158472 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 22, 1982
380 PIGGYBACK CONTROLLER
K823026 · LDR
Imed Corp.
General Hospital · 39d
Cleared Nov 22, 1982
ACCUDOT 380 SECONDARY I.V. SET
K823027 · FPA
Imed Corp.
General Hospital · 39d
Cleared Nov 22, 1982
HEMOGLOBIN REAGENT
K823060 · KHG
Biorent Diagnostic, Inc.
Chemistry · 35d
Cleared Nov 22, 1982
RAICHEM & GT REAGENT
K823090 · JPZ
Reagents Applications, Inc.
Chemistry · 34d
Cleared Nov 22, 1982
HEMAFLO BLOOD TUBING SETS
K823092 · FKQ
Cobe Laboratories, Inc.
Gastroenterology & Urology · 33d
Cleared Nov 22, 1982
NYSTYMOGRAPH ACCESS
K823111 · GNN
Kelleher Corp.
Microbiology · 28d
Cleared Nov 22, 1982
IMS HEMATOLOGY MIXER
K823124 · GLE
Innovative Medical Systems, Inc.
Hematology · 31d
Cleared Nov 22, 1982
URIC ACID STANDARD, 8MG/DL #65078
K823147 · JIS
Harleco Diagnostics
Chemistry · 28d
Cleared Nov 22, 1982
ARRIRM SCRUB BRUSH/SPONGE
K823173 · GEC
The Buckeye Cellulose Corp.
General & Plastic Surgery · 27d
Cleared Nov 22, 1982
MONOJECT SAMPLETTE CAPILLARY SERUM SEP
K823176 · JKA
Sherwood Medical Co.
Hematology · 27d
Cleared Nov 22, 1982
SA-21 DENTAL UNIT
K823180 · EIA
Ritter Co.
Dental · 21d
Cleared Nov 22, 1982
GAMMA LIGHT CURING DENTAL RESTORATIVE
K823185 · EBF
Johnson & Johnson Professionals, Inc.
Dental · 27d
Cleared Nov 22, 1982
CHOLESTEROL HIGH SENSIT. REAGENT ENZYM
K823187 · CHH
Rai, Inc.
Chemistry · 27d
Cleared Nov 22, 1982
CK-UV REAGENT
K823211 · JHS
Biorent Diagnostic, Inc.
Chemistry · 25d
Cleared Nov 22, 1982
DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI
K823213 · CJE
Boehringer Mannheim Corp.
Chemistry · 25d
Cleared Nov 22, 1982
VIEW-PACK & MULTI POUCH
K823223 · FRG
Sbw Medical Packaging, Inc.
General Hospital · 24d
Cleared Nov 22, 1982
SN-100 DOCTOR'S ROUND
K823226 · ETF
Kells Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Nov 22, 1982
IMPEDANCE METER ON-1
K823227 · ETY
Kells Medical, Inc.
Ear, Nose, Throat · 24d
Cleared Nov 22, 1982
NON-STERILE REUSABLE NEEDLES
K823255 · FMI
Vertex Medical Corp.
General Hospital · 21d
Cleared Nov 22, 1982
DENTAL FLOSS TIP
K823278 · JES
Sanderson Creative Products Co.
Dental · 19d
Cleared Nov 22, 1982
RESPOND QUADRIFLEX #3129 SINGLE CHANNEL
K823279 · IPF
Medtronic Vascular
Physical Medicine · 19d
Cleared Nov 22, 1982
DISTAFLEX
K823280 · EGG
Duradent Corp.
Dental · 19d
Cleared Nov 22, 1982
HEARING AID UE-10
K823365 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 12d
Cleared Nov 18, 1982
BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA
K823087 · CKB
Boehringer Mannheim Corp.
Chemistry · 30d