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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
101305–101328 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1995
AXSYM ACETAMINOPHEN
K953094 · LDP
Abbott Laboratories
Toxicology · 52d
Cleared Aug 24, 1995
OPUS T4 CONTROLS
K953097 · JJX
Behring Diagnostics, Inc.
Chemistry · 52d
Cleared Aug 24, 1995
OPUS T3
K953160 · CDP
Behring Diagnostics, Inc.
Chemistry · 48d
Cleared Aug 24, 1995
OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT
K953520 · DHR
Olympus America, Inc.
Immunology · 28d
Cleared Aug 24, 1995
ULTRA-BLEND
K953524 · EJK
Ultradent Products, Inc.
Dental · 28d
Cleared Aug 23, 1995
EBV LGG ELISA TEST
K941198 · LSE
Gull Laboratories, Inc.
Microbiology · 527d
Cleared Aug 23, 1995
PHONAK PICONET 232X-AZ HEARING INSTRUMENT
K945439 · ESD
Phonak, Inc.
Ear, Nose, Throat · 299d
Cleared Aug 23, 1995
MAGNETOM VISION (PROJECT 016)
K945779 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 271d
Cleared Aug 23, 1995
DMA TOTAL CHOLESTEROL PROCEDURE
K946161 · CHH
Data Medical Associates, Inc.
Chemistry · 247d
Cleared Aug 23, 1995
KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL
K950337 · EQJ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 208d
Cleared Aug 23, 1995
BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BLL-GRAFT
K950598 · LYC
Bio-Interfaces, Inc.
Dental · 195d
Cleared Aug 23, 1995
INFANT HEEL WARMER
K950680 · IMD
Baxter Healthcare Corp
Physical Medicine · 190d
Cleared Aug 23, 1995
IP500 NUCLEAR GAMMA CAMERA SYSTEM
K952109 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 110d
Cleared Aug 23, 1995
RAPID-FOAM
K952457 · IYE
The Soule Co., Inc.
Radiology · 89d
Cleared Aug 23, 1995
SIENET DICOM GATEWAY
K952533 · LMD
Siemens AG
Radiology · 83d
Cleared Aug 23, 1995
MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL
K952944 · MOS
Medical Advances, Inc.
Radiology · 58d
Cleared Aug 23, 1995
AQUAFLO HYDROGEL WOUND DRESSING & PACKER
K952945 · NAE
Sherwood Medical Co.
General & Plastic Surgery · 58d
Cleared Aug 23, 1995
CONCEIVE OVULATION PREDICTOR
K953063 · CEP
Quidel Corp.
Chemistry · 54d
Cleared Aug 23, 1995
UIMAT PUMP
K953132 · BTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 48d
Cleared Aug 23, 1995
OPUS B12
K953455 · CDD
Behring Diagnostics, Inc.
Chemistry · 35d
Cleared Aug 23, 1995
ACUFEX TAG ANCHOR
K953459 · MBI
Acufex Microsurgical, Inc.
Orthopedic · 30d
Cleared Aug 23, 1995
3M MODEL 8200P MULTIPRO BTE
K953543 · ESD
3M Company
Ear, Nose, Throat · 26d
Cleared Aug 23, 1995
CO2 ARTHROFLATOR
K953550 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 26d
Cleared Aug 23, 1995
SPECTACLE SUNGLASSES(NON-PRESCRIPTION)
K953629 · HQY
Lowinger Holdings, Inc.
Ophthalmic · 30d