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
112777–112800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 13, 1993
MILL-ROSE PULMONARY FORCEPS
K922204 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 428d
Cleared Jul 13, 1993
U P CUSTOM DESIGN, INC. COT EQUIPMENT CARRIER
K922816 · FPP
Up Custom Design, Inc.
General Hospital · 397d
Cleared Jul 13, 1993
TOTAL CONDYLAT TYPE KNEE SYSTEM
K922869 · JWH
Osteo Technology, Inc.
Orthopedic · 404d
Cleared Jul 13, 1993
VARIOUS MODELS OF SUNGLASSES
K922886 · HQY
Hard Rock Cafe, Inc.
Ophthalmic · 392d
Cleared Jul 13, 1993
URESIL BILLIARY CATHETER
K923096 · FGE
Uresil Corp.
Gastroenterology & Urology · 383d
Cleared Jul 13, 1993
TROPIC-AIR
K923104 · DWJ
Seabrook Medical Systems, Inc.
Cardiovascular · 383d
Cleared Jul 13, 1993
GENESIS SPRAY TIP ATOMIZER
K923183 · FMF
Mai
General Hospital · 378d
Cleared Jul 13, 1993
INTERMITTENT INJECTION SITE
K923323 · FOZ
Kawasumi Laboratories Co., Ltd.
General Hospital · 371d
Cleared Jul 13, 1993
NEEDLE-GRABBER
K923840 · GDF
Guardian Angel Products, Inc.
General & Plastic Surgery · 347d
Cleared Jul 13, 1993
PROPAK
K924118 · KCT
Dental Services, Inc.
General Hospital · 333d
Cleared Jul 13, 1993
ECLIPSE 2100(TM), MODIFICATION
K924213 · GEX
Elipse Surgical Technologies, Inc.
General & Plastic Surgery · 347d
Cleared Jul 13, 1993
PATIENT EXAMINATION GLOVES
K924386 · LYY
Wuhrlin Soplamed (M) Sdn Bhd
General Hospital · 316d
Cleared Jul 13, 1993
SURGEON'S GLOVE
K925030 · KGO
Wuhrlin Soplamed (M) Sdn Bhd
General Hospital · 281d
Cleared Jul 13, 1993
FIBRACOL COLLAGEN-ALGINATE DRESSING
K925548 · FMF
Johnson & Johnson Medical, Inc.
General Hospital · 252d
Cleared Jul 13, 1993
OTI EUROPEAN COMPRESSION SYSTEM
K925571 · HRS
Osteo-Technology Intl., Inc.
Orthopedic · 252d
Cleared Jul 13, 1993
DEBUSK TEMP. SYST. ESOPHAGEAL STETHOSCOPE
K925789 · BZT
Deroyal Industries, Inc.
Anesthesiology · 239d
Cleared Jul 13, 1993
TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE
K926217 · GBZ
Terumo Medical Corp.
General & Plastic Surgery · 215d
Cleared Jul 13, 1993
INTRASITE GEL
K926508 · NAE
Smith & Nephew United, Inc.
General & Plastic Surgery · 195d
Cleared Jul 13, 1993
ACOUSTIC ANALYZER AA30
K930260 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 175d
Cleared Jul 13, 1993
ALPHA
K930273 · IZZ
Raymax Medical Corp.
Radiology · 175d
Cleared Jul 13, 1993
ACCESSORY TO UNIVERSAL OCTOPAQUE
K930357 · KXH
Octostop, Inc.
Radiology · 168d
Cleared Jul 13, 1993
PNEUMATIC COMPRESSION DEVICE
K930885 · JAA
Bt Medical Co., Inc.
Radiology · 145d
Cleared Jul 13, 1993
INTREX INTERORAL DENTAL X-RAY UNIT
K930925 · EAP
Keystone X-Ray, Inc.
Radiology · 140d
Cleared Jul 13, 1993
BATTERY PACKS (VARIOUS MODELS)
K931200 · IZL
Access / God Loves You
Radiology · 126d