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
96457–96480 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1996
BREAST TREATMENT AID M200
K962487 · IYE
S. and H. Engineering, Inc.
Radiology · 75d
Cleared Sep 09, 1996
ACUTEK'S CLEARPASAGE
K962698 · LWF
Acutek Adhesive Specialties, Inc.
Ear, Nose, Throat · 84d
Cleared Sep 09, 1996
AUDIO 'D' K-AMP HR FULL SHELL AND CANAL HEARING AIDS
K962798 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 53d
Cleared Sep 09, 1996
SUSTAINED PHONATION
K962961 · KTH
Surface Mount Technology, Inc.
Ear, Nose, Throat · 41d
Cleared Sep 09, 1996
BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES
K963033 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 09, 1996
STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3
K963346 · JJY
Consolidated Technologies, Inc.
Chemistry · 14d
Cleared Sep 06, 1996
ELECTRONIC MUSCLE STIMULATOR MODEL EMS-1C/EMS-2C
K960457 · IPF
Med Labs, Inc.
Physical Medicine · 220d
Cleared Sep 06, 1996
MEDCARE REGIONAL ANETHESIA KIT
K961075 · CAZ
Medcare Medical Group, Inc.
Anesthesiology · 172d
Cleared Sep 06, 1996
BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
K961832 · CCW
Blue Ridge Medical, Inc.
Anesthesiology · 116d
Cleared Sep 06, 1996
NOBLEPHARMA WIDE ACCESSORIES
K962403 · DZE
Nobelpharma USA, Inc.
Dental · 77d
Cleared Sep 06, 1996
OSTEO COMPACTION KIT
K962449 · DZE
Steri-Oss, Inc.
Dental · 74d
Cleared Sep 06, 1996
SHIFA STERILE DISPOSABLE SYRINGES
K962614 · FMF
International Regulatory Consultants
General Hospital · 65d
Cleared Sep 06, 1996
VIGOR COMPRESSION HIP SCREW SYSTEM
K962644 · JDO
Deutschland Surgical, Inc.
Orthopedic · 60d
Cleared Sep 06, 1996
DERMISTICK SEPP APPLICATOR(200 CT)/(40 CT) 260640/260641
K962740 · KMF
Medi-Flex Hospital Products, Inc.
General & Plastic Surgery · 53d
Cleared Sep 06, 1996
TRI-PHASIX CHROMATIC ALGINATE
K962741 · ELW
Parkell, Inc.
Dental · 53d
Cleared Sep 06, 1996
ACRYNOODLES ABSORBENT WOUND DRESSING
K962851 · MGQ
Acrymed, Inc.
General & Plastic Surgery · 46d
Cleared Sep 06, 1996
UNITRON MODEL ICON KR
K963122 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 25d
Cleared Sep 06, 1996
DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
K963134 · EFQ
Igenics, Inc.
General & Plastic Surgery · 25d
Cleared Sep 05, 1996
NEWMED ABP-LITE
K955887 · DXW
Newmed Corp.
Cardiovascular · 252d
Cleared Sep 05, 1996
ELVIS HSV GOLD
K960578 · GQN
Diagnostic Hybrids, Inc.
Microbiology · 206d
Cleared Sep 05, 1996
GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3
K960860 · JKA
Greiner America, Inc.
Chemistry · 188d
Cleared Sep 05, 1996
SKIN DOSE MONITOR
K961105 · OWB
Mcmahon Medical
Radiology · 169d
Cleared Sep 05, 1996
DYNATRON 525
K961261 · LIH
Dynatronics Corp.
Neurology · 156d
Cleared Sep 05, 1996
ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
K961525 · MOS
Mri Devices Corp.
Radiology · 136d