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
135577–135600 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 25, 1988
SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN.
K880217 · DXK
Ge Medical Systems Information...
Cardiovascular · 96d
Cleared Apr 25, 1988
IMED(R) GEMINI(TM) PC-1 VOLUMETRIC INFUSION PUMP
K880479 · FRN
Imed Corp.
General Hospital · 80d
Cleared Apr 25, 1988
LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
K880592 · LLO
Laser Peripherals, LLC
Anesthesiology · 74d
Cleared Apr 25, 1988
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K880734 · HHI
Personal Products Co.
Obstetrics & Gynecology · 61d
Cleared Apr 25, 1988
UNSCENTED MENSTRUAL PADS
K880735 · HHD
Personal Products Co.
Obstetrics & Gynecology · 61d
Cleared Apr 25, 1988
RELIANCE METAL PRIMER
K880766 · DYH
Reliance Orthodontic Products, Inc.
Dental · 59d
Cleared Apr 25, 1988
CULTURE COLLECTION DEVICE
K881105 · JSM
Medical Packaging Corp.
Microbiology · 41d
Cleared Apr 25, 1988
PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT
K881141 · CAI
Baxter Healthcare Corp
Anesthesiology · 39d
Cleared Apr 25, 1988
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
K881277 · LSL
Gen-Probe, Inc.
Microbiology · 38d
Cleared Apr 25, 1988
RONDEX RESCUE MASK
K881393 · BSJ
Rondex Products, Inc.
Anesthesiology · 21d
Cleared Apr 25, 1988
YANKAUER SUCTION INSTRU./LAYTEX GLOVES/SUCT. CATH.
K881429 · CAZ
Medical Repackers Co.
Anesthesiology · 27d
Cleared Apr 22, 1988
S-ROM SUPERCUP ACETABULAR CUP
K870088 · LWJ
Joint Medical Products Corp.
Orthopedic · 469d
Cleared Apr 22, 1988
EUB-305 DIAGNOSTIC ULTRASOUND DEVICE
K870878 · DXK
Hitachi Medical Corp. of America
Cardiovascular · 415d
Cleared Apr 22, 1988
REI-38 RADIOGRAPHIC TABLE
K873702 · IXQ
Radiological Engineering, Inc.
Radiology · 221d
Cleared Apr 22, 1988
ELECTRIC MOBILITY'S SPARKY
K874739 · ITI
Electric Mobility Corp.
Physical Medicine · 156d
Cleared Apr 22, 1988
PERIPHERAL DILATATION CATHETER
K880298 · LIT
Medi-Tech, Inc.
Cardiovascular · 88d
Cleared Apr 22, 1988
ANGIO DRAPE PACK ACP-010FM
K880310 · DXT
Arrow Intl., Inc.
Cardiovascular · 88d
Cleared Apr 22, 1988
MIC (SPECIFIC LINE) REPLACEMENT KIT
K880768 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 56d
Cleared Apr 22, 1988
A2J MZ 44 B TYPE
K880981 · IWE
A2j, Inc.
Radiology · 45d
Cleared Apr 22, 1988
LEUKOPOR(TM) SURGICAL TAPE
K881509 · KGX
Beiersdorf, Inc.
General & Plastic Surgery · 11d
Cleared Apr 21, 1988
VEOLAR VENTILATOR
K871792 · CBK
Hamilton Medical, Inc.
Anesthesiology · 350d
Cleared Apr 21, 1988
ANKLE REFLEX TREATMENT UNIT (ARTU)
K873658 · BXB
Universal Gym Equipment, Inc.
Physical Medicine · 224d
Cleared Apr 21, 1988
MUSCULOSKELETAL EVALUATION REHABILITATION/CONDITIO
K873659 · IKK
Universal Gym Equipment, Inc.
Physical Medicine · 224d
Cleared Apr 21, 1988
TDX (R) AMPHETAMINE CLASS
K874770 · DKZ
Abbott Laboratories
Toxicology · 154d