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
159289–159312 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 24, 1982
MACRODOT ADD-I-MED ADMIN. SET
K823347 · FPA
Imed Corp.
General Hospital · 15d
Cleared Nov 24, 1982
LATERAL POSITIONER
K823398
Orthopedic Systems, Inc.
General & Plastic Surgery · 12d
Cleared Nov 23, 1982
MODEL 900 PHOTOCOAGULATOR WITH GREEN-ONLY OPTIONS
K827383
Coherent Radiation Laboratories
Radiology · 25d
Cleared Nov 22, 1982
ENT TREATMENT UNITS
K822252 · ETF
Kelleher Corp.
Ear, Nose, Throat · 116d
Cleared Nov 22, 1982
AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC
K822809 · JTN
General Diagnostics
Microbiology · 63d
Cleared Nov 22, 1982
HALO TRACTION CERVICAL IMMOBILIZATION
K822885 · HAX
Orthopedic Systems, Inc.
Neurology · 55d
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