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
96529–96552 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 30, 1996
OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE
K961697 · EZL
Medical Device Intl., Inc.
Gastroenterology & Urology · 120d
Cleared Aug 30, 1996
S-41 & S-41S VIDEO IMAGING SYSTEM
K962020 · GCJ
Del Medical Systems Corp.
General & Plastic Surgery · 99d
Cleared Aug 30, 1996
VALLEYLAB COATED ELECTRODES
K962044 · GEI
Valleylab, Inc.
General & Plastic Surgery · 94d
Cleared Aug 30, 1996
COBAS CORE IMMUNOCHEMISTRY SYSTEM
K962231 · JJE
Roche Diagnostic Systems, Inc.
Chemistry · 81d
Cleared Aug 30, 1996
SYNTHES MANDIBLE DISTRACTOR
K962272 · MQN
Synthes (Usa)
Dental · 78d
Cleared Aug 30, 1996
VIDAS CREATINE KINASE MB ASSAY 30-421
K962549 · JHX
Biomerieux Vitek, Inc.
Chemistry · 63d
Cleared Aug 30, 1996
GRAM NEGATIVE IDENTIFICATION PLUS CARD
K962609 · LRH
Biomerieux Vitek, Inc.
Microbiology · 58d
Cleared Aug 30, 1996
ACCUSIGN BZO-RAPID ONE-STEP BENZODIAZEPINE ASSAY
K962672 · JXM
Princeton BioMeditech Corp.
Toxicology · 52d
Cleared Aug 30, 1996
DSL 9100 IGF-II IRMA
K962758 · CFL
Diagnostic Systems Laboratories, Inc.
Chemistry · 45d
Cleared Aug 30, 1996
ETEST FOR AZTREONAM
K962794 · JWY
Ab Biodisk
Microbiology · 44d
Cleared Aug 30, 1996
SEALEX EXTRA ROOT CANAL SEALER
K962885 · KIF
Baladent
Dental · 37d
Cleared Aug 30, 1996
ELECSYS CALCHECK HCG
K963165 · JJX
Boehringer Mannheim Corp.
Chemistry · 16d
Cleared Aug 29, 1996
CORPAK REPLACEMENT GASTROSTOMY DEVICE STOMACORE
K935512 · KNT
Corpak Co.
Gastroenterology & Urology · 1017d
Cleared Aug 29, 1996
TROJAN POLYURETHANE CONDOM (MODIFICATION)
K955672 · MOL
Carter Products
Obstetrics & Gynecology · 302d
Cleared Aug 29, 1996
STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION
K960003 · HQC
Storz Instrument Co.
Ophthalmic · 240d
Cleared Aug 29, 1996
CERVICAL MUCOUS ASPIRATION CATHETER
K960263 · HFC
Cook Urological, Inc.
Obstetrics & Gynecology · 224d
Cleared Aug 29, 1996
MITYVAC DIRECTIONAL VACUUM EXTRACTOR, DISPOSABLE
K960549 · HDB
Neward Enterprises, Inc.
Obstetrics & Gynecology · 203d
Cleared Aug 29, 1996
KSEA VAPORIZATION ELECTRODES
K961702 · FAS
Karl Storz Endoskop GmbH
Gastroenterology & Urology · 119d
Cleared Aug 29, 1996
A4907 LENS CLEANING SHEATH
K961860 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 107d
Cleared Aug 29, 1996
VENTRICULAR CATHETER SET
K962097 · JXG
Cook, Inc.
Neurology · 92d
Cleared Aug 29, 1996
SPLINE DENTAL IMPLANT SYSTEMS
K962106 · DZE
Calcitek, Inc.
Dental · 90d
Cleared Aug 29, 1996
CAMBRIDGE HEART HI-RES ECG ELECTRODE
K962115 · DRX
Cambridge Heart, Inc.
Cardiovascular · 90d
Cleared Aug 29, 1996
D.O.R.C. MICRODIATHERMY SYSTEM
K962135 · HQO
Dutch Ophthalmic USA, Inc.
Ophthalmic · 87d
Cleared Aug 29, 1996
P.F.C. CERAMIC HIP HEAD
K962248 · LZO
Johnson & Johnson Professionals, Inc.
Orthopedic · 79d