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
134953–134976 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1988
AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP.
K882135 · EFB
Vita Dental Co.
Dental · 33d
Cleared Jun 22, 1988
2P-QDA FOOT PRESSURE SYSTEMS REAL TIME
K882139 · JFC
Human Performance Technologies, Inc.
Physical Medicine · 30d
Cleared Jun 22, 1988
COHERENT SYSTEM 920 ARGON/DYE PHOTOCOAGULATOR
K882160 · GEX
Coherent Medical Lasers
General & Plastic Surgery · 30d
Cleared Jun 22, 1988
ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60
K882185 · HIF
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 29d
Cleared Jun 22, 1988
ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL
K882277 · GQG
Abbott Laboratories
Microbiology · 22d
Cleared Jun 22, 1988
SHAW SUN SYSTEMS MODEL 1600
K882331 · LEJ
Shaw Sun Systems
General & Plastic Surgery · 16d
Cleared Jun 22, 1988
STAT FIX MICROWAVE IRRADIATION MEDIUM
K882362 · LDJ
Stat Path
Pathology · 15d
Cleared Jun 22, 1988
POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421
K882463 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 7d
Cleared Jun 21, 1988
TRANSONIC FLOWMETER
K872048 · DPW
Transonic Systems, Inc.
Cardiovascular · 390d
Cleared Jun 21, 1988
KONTRON CAPNOGRAPH MONITOR, SUPERMON MODULE 7281
K873396 · CCK
Kontron Instruments, Inc.
Anesthesiology · 302d
Cleared Jun 21, 1988
ACUSON S328 TRANSDUCER
K874028 · IYO
Acuson Computed Sonography
Radiology · 263d
Cleared Jun 21, 1988
ORCEPAD
K875123 · HDD
Alton Dean Medical, Inc.
Obstetrics & Gynecology · 189d
Cleared Jun 21, 1988
OKAMOTO CONDOMS SPERMICIDALLY LUBRICATED
K880820 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 112d
Cleared Jun 21, 1988
XOMED AUDIANT BONE CONDUCTOR
K881382 · LXB
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Jun 21, 1988
BIOPSY GUIDE
K881605 · IYO
Teknar, Inc.
Radiology · 84d
Cleared Jun 21, 1988
CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL
K881625 · BZE
Respiratory Care, Inc.
Anesthesiology · 70d
Cleared Jun 21, 1988
AUTOMATIC CALORIC IRRIGATION SYSTEM
K881630 · KHH
Ics Medical Corp.
Ear, Nose, Throat · 68d
Cleared Jun 21, 1988
SAFETY DRAIN
K881790 · BYH
Ballard Medical Products
Anesthesiology · 56d
Cleared Jun 21, 1988
DENTAL BURS
K882183 · EJL
Tri-Stage, Inc.
Dental · 28d
Cleared Jun 21, 1988
MEDIBLEND (TM) LUNG DIFFUSION GAS MIXTURES
K882210 · BXK
Linde Div. Union Carbide Corp.
Anesthesiology · 26d
Cleared Jun 21, 1988
SULLIVAN NASAL CPAP SYSTEM
K882292 · BYE
Baxter Centre For Medical Research
Anesthesiology · 20d
Cleared Jun 21, 1988
ASEPTIP
K882399 · EKJ
Koppa Innovative Dental Products, Inc.
Dental · 11d
Cleared Jun 20, 1988
FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM
K880061 · GEX
Abbott Laboratories
General & Plastic Surgery · 165d
Cleared Jun 20, 1988
LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL
K880145 · DIF
Bio-Rad
Toxicology · 159d