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
152713–152736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1984
MINOLTA SM-32 OXYGEN SATURATION MONIT
K833973 · DQA
Marquest Medical Products, Inc.
Anesthesiology · 175d
Cleared May 09, 1984
MODEM ACCESSORY FOR EPI CARDIA SYS
K834034 · DXH
Medicomp, Inc.
Cardiovascular · 168d
Cleared May 09, 1984
ULTRASOUND SCANNER 501
K834284 · IYO
Imex Medical Systems, Inc.
Radiology · 166d
Cleared May 09, 1984
SWITCHING UNIT ELECTRODE CATHETER
K834602 · DRF
Webster Laboratories, Inc.
Cardiovascular · 131d
Cleared May 09, 1984
IREX 720 SECTOR SCANNER
K840139 · IYO
Irex Corp.
Radiology · 126d
Cleared May 09, 1984
HEALTHCHECK AUTO INFLATE DIGITAL BP
K840228 · DXN
Timex Medical Products Corp.
Cardiovascular · 110d
Cleared May 09, 1984
NON STRESS TEST MONITOR 507
K840285 · HGH
Imex Medical Systems, Inc.
Obstetrics & Gynecology · 106d
Cleared May 09, 1984
CAT. 7-EAR, NOSE & THROAT DEVICES
K840311 · KCP
Imm Enterprises , Ltd.
Ear, Nose, Throat · 106d
Cleared May 09, 1984
AUDIO BANDWIDTH ANALYZER
K840402 · IYN
D. E. Hokanson, Inc.
Radiology · 99d
Cleared May 09, 1984
OPTHERM FINE TIP
K840425 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
OPTHERM EXTRA FINE TIP
K840426 · HQP
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE BLUE SPOT
K840427
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE PEN LIGHT
K840428
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
SUN-LITE WHITE SLIT
K840430
Suncoast Medical Manufacturers, Inc.
Ophthalmic · 99d
Cleared May 09, 1984
BIOPSY ATTACHMENT
K840451 · IYO
Elscint, Inc.
Radiology · 98d
Cleared May 09, 1984
SUN-LITE BLUE SLIT
K840492 · HTP
Suncoast Medical Manufacturers, Inc.
Orthopedic · 93d
Cleared May 09, 1984
TECHNICARE MODEL 330
K840540 · IYO
Technicare Corp.
Radiology · 91d
Cleared May 09, 1984
FLEISCHMAN-SWARTZ ENDO-OCULAR PROBE
K840590 · HQF
Hgm, Inc.
Ophthalmic · 90d
Cleared May 09, 1984
LENS INSERTION GLIDE
K840694 · KYB
Innovative Surgical Products, Inc.
Ophthalmic · 83d
Cleared May 09, 1984
CORNEAL SCLERAL LANCE
K840855 · HNN
Sharpoint, Inc.
Ophthalmic · 75d
Cleared May 09, 1984
TSE-ANDERSON MODIFIED LACRIMAL GROOV
K840861 · HNL
Hansen Ophthalmic Development Lab
Ophthalmic · 75d
Cleared May 09, 1984
SITE COAXIAL I/A HANDPIECE 30 TIP
K840965 · HQC
Chiron Vision Corp.
Ophthalmic · 64d
Cleared May 09, 1984
LACHRYMAL PROBES-VARIOUS
K841002 · HNW
Premier Dental Products Co.
Ophthalmic · 61d
Cleared May 09, 1984
OPHTHALMIC CURETTE-VARIOUS
K841007 · HNZ
Premier Dental Products Co.
Ophthalmic · 61d