FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
121657–121680 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 24, 1991
INTERVASCULAR ADMINSTRATION SET
K911753 · FPA
Mcgaw, Inc.
General Hospital · 67d
Cleared Jun 24, 1991
MONARCH STERILIZATION CONTAINER SYST, MODIFICATION
K911760 · FRG
Monarch Products, Inc.
General Hospital · 73d
Cleared Jun 24, 1991
INFANT NASAL CANNULAE ASSEMBLY, MODIFIED
K911780 · BZD
Ackrad Laboratories
Anesthesiology · 63d
Cleared Jun 24, 1991
INTERLINK(TM) BLUNT CANNULA, MODIFICATION
K911868 · FPA
Baxter Healthcare Corp
General Hospital · 59d
Cleared Jun 24, 1991
MODEL 700 LAPAROSCOPIC ELECTRONIC INSUFFLATOR
K912044 · HIF
Multigon Industries, Inc.
Obstetrics & Gynecology · 47d
Cleared Jun 24, 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · EKJ
Premier Dental Products Co.
Dental · 40d
Cleared Jun 24, 1991
SX90 (TM),MODEL 4800S
K912348 · GZJ
Medical Devices, Inc.
Neurology · 27d
Cleared Jun 24, 1991
MODEL 404-SP AND 504-SP INFUSION PUMPS MODIFIED
K912458 · FRN
Medtronic Minimed
General Hospital · 31d
Cleared Jun 24, 1991
BIPOLAR FORCEPS
K912544 · MAV
Everest Medical Corp.
Cardiovascular · 14d
Cleared Jun 21, 1991
LYME IGM ELISA TEST
K903013 · LSR
Gull Laboratories, Inc.
Microbiology · 345d