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
106561–106584 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1994
AMSCO STERILE RECOVERIES SURGICAL PACKS
K932522 · LRD
Amsco Sterile Recoveries, Inc.
Ear, Nose, Throat · 472d
Cleared Sep 09, 1994
FASCOUNT SYSTME
K933486 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 417d
Cleared Sep 09, 1994
GONOCHEK-II, MODIFICATION
K934125 · JTO
E-Y Laboratories, Inc.
Microbiology · 393d
Cleared Sep 09, 1994
CULTURIA MACCONKEY-MUG
K934759 · JXA
Clinical Convenience Products, Inc.
Microbiology · 340d
Cleared Sep 09, 1994
THIXOFLEX
K935896 · ELW
Zhermack Dental Production
Dental · 332d
Cleared Sep 09, 1994
CONCORD/PORTEX EPIDURAL CATHETERS
K935927 · BSO
Smiths Industries Medical Systems, Inc.
Anesthesiology · 270d
Cleared Sep 09, 1994
CINEMAC QAS
K936002 · IZI
Xre Corp.
Radiology · 268d
Cleared Sep 09, 1994
B-LACTAMASE REAGENT TUBES
K940161 · JTO
E-Y Laboratories, Inc.
Microbiology · 240d
Cleared Sep 09, 1994
GONOCHEK II REAGENT TUBES
K940162 · JTO
E-Y Laboratories, Inc.
Microbiology · 240d
Cleared Sep 09, 1994
URINE REAGENT STRIP-3 PARAMETERS
K940469 · JIL
Teco Diagnostics
Chemistry · 219d
Cleared Sep 09, 1994
KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE
K940594 · FGA
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 212d
Cleared Sep 09, 1994
REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222
K940679 · JHO
Helena Laboratories
Chemistry · 212d
Cleared Sep 09, 1994
COMBO MASK
K941336 · KGB
Gam Industries, Inc.
Anesthesiology · 172d
Cleared Sep 09, 1994
PLASMINOGEN RID TEST KIT
K941346 · DDX
The Binding Site, Ltd.
Immunology · 172d
Cleared Sep 09, 1994
PROSPECT GIARDIA
K942098 · MHI
Alexon, Inc.
Microbiology · 148d
Cleared Sep 09, 1994
E-VAC-U-ACCESSORIES
K942520 · EIA
Bull Frog Mfg. Co.
Dental · 106d
Cleared Sep 09, 1994
THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED
K942552 · DIF
Medi-Tech, Inc.
Toxicology · 101d
Cleared Sep 09, 1994
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K942560 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 101d
Cleared Sep 09, 1994
TNT TROPONIN T
K942632 · JJX
Streck Laboratories, Inc.
Immunology · 98d
Cleared Sep 09, 1994
DUPONT DIMENSION AMYLASE METHOD
K942640 · JFJ
Dupont Medical Products
Chemistry · 98d
Cleared Sep 09, 1994
QMS THEOPHYLLINE CS
K942991 · LGS
Seradyn, Inc.
Toxicology · 81d
Cleared Sep 09, 1994
ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOR
K943182 · EFS
Oral-B Laboratories
Dental · 70d
Cleared Sep 09, 1994
PROPOXPHENE EIA TEST
K943414 · JXN
Diagnostic Reagents, Inc.
Toxicology · 56d
Cleared Sep 09, 1994
MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER
K943485 · FMI
Sherwood Medical Co.
General Hospital · 52d