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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
96913–96936 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 31, 1996
CHROMOLIZE TPA ASSAY KIT
K962489 · GGP
Medical Diagnostic Technologies, Inc.
Hematology · 35d
Cleared Jul 30, 1996
RPR LIQUID CONTROLS
K955143 · GMP
Remel, L.P.
Microbiology · 260d
Cleared Jul 30, 1996
ISOLETTE INFANT INCUBATOR
K960980 · FMZ
Air-Shields, Inc.
General Hospital · 141d
Cleared Jul 30, 1996
PYLORI IGG ELISA TEST SYSTEM
K961221 · LYR
Armkel, LLC
Microbiology · 132d
Cleared Jul 30, 1996
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT...
K961679 · DTB
Medtronic Vascular
Cardiovascular · 90d
Cleared Jul 30, 1996
DALE GASTROSTOMY TUBE HOLDER
K961693 · PLI
Dale Medical Products, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 30, 1996
DRAGER GEMINA WALL-MOUNTED WORKPLACE
K961886 · FQO
Alm Surgical Equipment, Inc.
General & Plastic Surgery · 76d
Cleared Jul 30, 1996
BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER
K962077 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 30, 1996
MLI SOFT TISSUE SCREW & WASHER SYSTEM
K962194 · MBI
Medicinelodge, Inc.
Orthopedic · 53d
Cleared Jul 30, 1996
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
K962445 · EKZ
Arthrocare Corp.
Dental · 36d
Cleared Jul 30, 1996
OLYMPUS FB SERIES BIOPSY FORCEPS
K962555 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 29, 1996
NITELIFE BI-LEVEL CPAP
K943207 · BZD
Airsep Corp.
Anesthesiology · 755d
Cleared Jul 29, 1996
BIPAP MODEL S/T-D
K951264 · MNT
Respironics, Inc.
Anesthesiology · 496d
Cleared Jul 29, 1996
RPR CARD TEST KIT
K955136 · GMQ
Remel, L.P.
Microbiology · 259d
Cleared Jul 29, 1996
POWDER FREE PLUS HYPOALLERGENIC (WITH LABELED PROTEIN CONTENT) PATIENT...
K960225 · LYY
Tillotson Healthcare Corp.
General Hospital · 194d
Cleared Jul 29, 1996
ULTRA CARE POWDER FREE HYPOALLERGENIC PATIENT EXAMINATION GLOVE
K960247 · LYY
Tillotson Healthcare Corp.
General Hospital · 195d
Cleared Jul 29, 1996
PROTEC STERILE GAUZE SPONGE
K961773 · EFQ
Derivadas Degasa S.A. DE C.V.
General & Plastic Surgery · 82d
Cleared Jul 29, 1996
POLYESTER NONABSORBABLE SURGICAL SUTURES USP
K961925 · GAT
R. K. Medical L. L. C.
General & Plastic Surgery · 73d
Cleared Jul 29, 1996
PLAIN GUT & CHRONIC GUT ABSORBABLE SURGICAL SUTURES USP
K961931 · GAL
R. K. Medical L. L. C.
General & Plastic Surgery · 73d
Cleared Jul 29, 1996
NHMC URETHRAL CATHETERIZATION TRAY
K962254 · FCM
National Healthcare Mfg. Corp.
Gastroenterology & Urology · 47d
Cleared Jul 29, 1996
N/T PROTEIN CONTROL PY
K962407 · GIL
Behring Diagnostics, Inc.
Hematology · 38d
Cleared Jul 29, 1996
FACTPLUS ONE STEP PREGNANCY TEST
K962521 · LCX
Direct Access Diagnostics
Chemistry · 40d
Cleared Jul 29, 1996
MILL-ROSE LARYNGOSCOPIC INJECTION NEEDLE
K962736 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 14d
Cleared Jul 26, 1996
ECHO. AKHO
K951976 · IYO
Alliance Medical, Inc.
Radiology · 456d