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
95521–95544 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1996
CONTRAST STRIP HCG
K964156 · JHI
Genzyme Diagnostics
Chemistry · 40d
Cleared Nov 25, 1996
TRACE RITE SOLID GEL ECG ELECTRODES
K964213 · DRX
Bio-Detek, Inc.
Cardiovascular · 34d
Cleared Nov 25, 1996
SUNGLASSES(NON-PRESCRIPTION)
K964413 · HQY
Ever Prime Enterprises , Ltd.
Ophthalmic · 55d
Cleared Nov 25, 1996
ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL
K964422 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 20d
Cleared Nov 22, 1996
TEX-CARE STERILE STOCKINETTE
K955749 · KKX
Flynt Amtex, Inc.
General Hospital · 339d
Cleared Nov 22, 1996
UNISEAL GLOVES (LOW PROTEIN,POWDER FREE)
K963211 · LYY
American Healthcare Products, Inc.
General Hospital · 98d
Cleared Nov 22, 1996
DRESSING CHANGE TRAYS
K963260 · FMF
Busse Hospital Disposables, Inc.
General Hospital · 94d
Cleared Nov 22, 1996
PHASED ARRAY SHOULDER COIL
K963356 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Nov 22, 1996
HOLOGIC QDR SERIES X-RAY BOE DENSITOMETERS
K963363 · KGI
Hologic, Inc.
Radiology · 87d
Cleared Nov 22, 1996
POSEY STRAIGHT JACKETS
K963410 · FMQ
J. T. Posey Co.
General Hospital · 84d
Cleared Nov 22, 1996
MULTIPLE BELTS
K963414 · FMQ
J. T. Posey Co.
General Hospital · 84d
Cleared Nov 22, 1996
PROTECTIVE RESTRAINT (WAIST HOLDER)
K963421 · FMQ
Kenad SG Medical, Inc.
General Hospital · 84d
Cleared Nov 22, 1996
PROTECTIVE RESTRAINT (PROTECTIVE MITT)
K963422 · FMQ
Kenad SG Medical, Inc.
General Hospital · 84d
Cleared Nov 22, 1996
PROTECTIVE RESTRAINT (VEST RESTRAINT)
K963430 · FMQ
Kenad SG Medical, Inc.
General Hospital · 84d
Cleared Nov 22, 1996
RESTRAINT ACCESSORIES
K963436 · FMQ
J. T. Posey Co.
General Hospital · 84d
Cleared Nov 22, 1996
JACKETS AND VESTS
K963442 · FMQ
J. T. Posey Co.
General Hospital · 84d
Cleared Nov 22, 1996
SILICONE RUBBER CUFF/DISPOSABLE FLEECE LINER'S WEB TORSO RESRAINT,NYON LIMB...
K963485 · FMQ
Humane Restraint, Inc.
General Hospital · 80d
Cleared Nov 22, 1996
QUICK RELEASE LIMB HOLDER (24442,24442-050,24442-350)
K963552 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 78d
Cleared Nov 22, 1996
WRPAROUND LIMB HOLDER (24446,24446-350,24447-010,24449-010)
K963559 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 78d
Cleared Nov 22, 1996
PERSONAL LIMB HOLDER (24444-200,300,24444-KIT)
K963564 · FMQ
Tecnol Medical Products, Inc.
General Hospital · 78d
Cleared Nov 22, 1996
RETRIEVAL SNARE
K963750 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 65d
Cleared Nov 22, 1996
CDR-CAM
K963778 · EIA
Schick Technologies, Inc.
Dental · 63d
Cleared Nov 22, 1996
WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY...
K964278 · JJX
Clinical Controls, Inc.
Chemistry · 25d
Cleared Nov 22, 1996
PARAMAX AMMONIA AND AMMONIA BLANK REAGENT
K964565 · JIF
Dade Intl., Inc.
Chemistry · 8d