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
97153–97176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1996
WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961296 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 97d
Cleared Jul 10, 1996
NOVA LITE ANCA
K961340 · MOB
Inova Diagnostics, Inc.
Immunology · 107d
Cleared Jul 10, 1996
AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE
K961362 · DXH
Aerotel, Ltd.
Cardiovascular · 92d
Cleared Jul 10, 1996
INTRAN 500
K961424 · HFN
Utah Medical Products, Inc.
Obstetrics & Gynecology · 89d
Cleared Jul 10, 1996
WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS
K961507 · JCT
Boston Scientific Scimed, Inc.
General & Plastic Surgery · 82d
Cleared Jul 10, 1996
ACUFEX TAG BIOABSORBABLE ANCHORS
K961555 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 79d
Cleared Jul 10, 1996
SUTURE ANCHOR
K961578 · JDR
United States Surgical, A Division of...
Orthopedic · 77d
Cleared Jul 10, 1996
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
K961579 · GKP
American Bioproducts Co.
Hematology · 77d
Cleared Jul 10, 1996
SURGICAL DYNAMICS POP RIVET
K961585 · JDR
United States Surgical, A Division of...
Orthopedic · 77d
Cleared Jul 10, 1996
P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
K961685 · JWH
Johnson & Johnson Professionals, Inc.
Orthopedic · 70d
Cleared Jul 10, 1996
MIRUSCONE ABUTMENT SYSTEM
K961728 · NHA
Nobelpharma USA, Inc.
Dental · 68d
Cleared Jul 10, 1996
CERA ONE ABUTMENT SYSTEM
K961737 · DZE
Nobelpharma USA, Inc.
Dental · 68d
Cleared Jul 10, 1996
SAFETY RELEASE MODULE
K961754 · DZB
G & H Wire Co.
Dental · 65d
Cleared Jul 10, 1996
GENTAMICIN DISK (120MCG)
K961818 · JTN
Remel, L.P.
Microbiology · 61d
Cleared Jul 10, 1996
STREPTOMYCIN DISK (300MCG)
K961819 · JTN
Remel, L.P.
Microbiology · 61d
Cleared Jul 10, 1996
QUANTA LITE ENA 6 ELISA
K961913 · LLL
Inova Diagnostics, Inc.
Immunology · 54d
Cleared Jul 10, 1996
INNERDYNE STEP TROCAR EXPANDABLE PORT, ONESTEP
K961940 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 51d
Cleared Jul 10, 1996
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE,...
K962183 · LCX
Armkel, LLC
Chemistry · 34d
Cleared Jul 10, 1996
N LATEX CRP MONO REAGENT
K962523 · DCK
Behring Diagnostics, Inc.
Immunology · 41d
Cleared Jul 09, 1996
MEDI-TRACE DEFIB PADS
K955597 · GYB
Graphic Controls Corp.
Neurology · 214d
Cleared Jul 09, 1996
RD-1200H NORMAL MODE RUBY LASER SYSTEM
K955612 · GEX
Spectrum Medical Technologies, Inc.
General & Plastic Surgery · 214d
Cleared Jul 09, 1996
BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
K960555 · MAI
Instrument Makar, Inc.
Orthopedic · 151d
Cleared Jul 09, 1996
FLEXART QD HEAD/NECK COIL
K961391 · MOS
Toshiba America Mri, Inc.
Radiology · 90d
Cleared Jul 09, 1996
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K961445 · DQX
Terumo Medical Corp.
Cardiovascular · 84d