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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
121057–121080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 24, 1991
L582 TRANSDUCER
K904600 · MAA
Acuson Corp.
Radiology · 257d
Cleared Jun 24, 1991
BARD ALFENTANIL INFUSER
K904890 · FRN
C.R. Bard, Inc.
General Hospital · 237d
Cleared Jun 24, 1991
TMP MANDIBULAR COMPRESSION SYSTEM
K905024 · HRS
Techmedica, Inc.
Orthopedic · 229d
Cleared Jun 24, 1991
MTS KNEE SYSTEM
K905613 · JWH
T & R Mfg., Inc.
Orthopedic · 192d
Cleared Jun 24, 1991
SEAL-RITE SILICONE EAR PLUG
K910177 · EWD
Flents Products Co., Inc.
Ear, Nose, Throat · 160d
Cleared Jun 24, 1991
POCKET DOP 3
K910462 · HEP
Imex Medical Systems, Inc.
Radiology · 140d
Cleared Jun 24, 1991
VISUWELL SYPHILIS ANTIGEN
K910487 · LIP
Adi Diagnostics, Inc.
Microbiology · 138d
Cleared Jun 24, 1991
HGM ARGON ION & SOLID LIGHT LASER FOR DENTISTRY
K910602 · GEX
Hgm Medical Laser Systems, Inc.
General & Plastic Surgery · 131d
Cleared Jun 24, 1991
COLOR VUE TM- MYCOPLASMA PNEUMONIAE
K910833 · GSA
Seradyn, Inc.
Microbiology · 117d
Cleared Jun 24, 1991
MOSS- ANCHOR SET
K910910 · KNT
Moss Medical Products
Gastroenterology & Urology · 111d
Cleared Jun 24, 1991
CATHLAB SILICONE OCCLUSION BALLOON CATHETER
K910916 · DQT
Cathlab Corp.
Cardiovascular · 111d
Cleared Jun 24, 1991
FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM
K910934 · FRN
Baxter Healthcare Corp
General Hospital · 110d
Cleared Jun 24, 1991
OBA(TM) READER
K911045 · JJQ
Adeza Biomedical
Chemistry · 108d
Cleared Jun 24, 1991
OBA(TM) SERUM HCG ASSAY
K911047 · JHI
Adeza Biomedical
Chemistry · 108d
Cleared Jun 24, 1991
IRRIGATION/ASPIRATION TUBING SET
K911324 · KDH
Biomedical Dynamics, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 24, 1991
HARMONIC SCALPEL ENDOSCOPIC BLADE COUPLER EXTENSIO
K911341 · GEI
Ultracision, Inc.
General & Plastic Surgery · 90d
Cleared Jun 24, 1991
EMC MODEL NO. STATOME 900
K911353 · HAM
Emc Industries
General & Plastic Surgery · 89d
Cleared Jun 24, 1991
CATHETER MOUNTS
K911421 · BZA
Intersurgical, Inc.
Anesthesiology · 139d
Cleared Jun 24, 1991
ACCESSORIES & CONNECTORS, 22MM-15MM-8.5MM
K911425 · BZA
Intersurgical, Inc.
Anesthesiology · 139d
Cleared Jun 24, 1991
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
K911429 · LQM
Vitek Systems, Inc.
Microbiology · 90d
Cleared Jun 24, 1991
VITAL-PORT VASCULAR ACCESS SYSTEM
K911449 · LJT
Med Institute, Inc.
General Hospital · 96d
Cleared Jun 24, 1991
FASTTECH SYSTEM 1
K911496 · LSR
3M Diagnostic Systems, Inc.
Microbiology · 81d
Cleared Jun 24, 1991
MODEL 2100 PORTABLE FIELD UNIT
K911506 · EIA
Dntl Corp.
Dental · 81d
Cleared Jun 24, 1991
MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST
K911634 · CEC
Immunotech Corp.
Chemistry · 74d