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
102817–102840 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 16, 1995
ORTHO ALT MICROWELL TEST SYSTEM
K941192 · CKD
Ortho Diagnostic Systems, Inc.
Chemistry · 428d
Cleared May 16, 1995
INTEGRAL VI BIOINTEGRATED DENTAL IMPLANT SYSTEM
K944327 · DZE
Calcitek, Inc.
Dental · 256d
Cleared May 16, 1995
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 225d
Cleared May 16, 1995
LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3
K945651 · JJY
Bio-Rad
Immunology · 180d
Cleared May 16, 1995
ACE(TM) CEDIA(R) FERRITIN ASSAY
K950393 · JMG
Schiapparelli Biosystems, Inc.
Chemistry · 104d
Cleared May 16, 1995
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
K950455 · JOS
Aaron Medical Industries
General & Plastic Surgery · 102d
Cleared May 16, 1995
MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
K950681 · IKZ
Invacare Corp.
Physical Medicine · 91d
Cleared May 16, 1995
DRYSLIDE COAGULASE
K950706 · JTL
Difco Laboratories, Inc.
Microbiology · 90d
Cleared May 16, 1995
TRANSIT-2 INFUSION CATHETER
K950909 · DQO
Cordis Neurovascular, Inc.
Cardiovascular · 91d
Cleared May 16, 1995
ABBOTT AXSYM II SYSTEM
K950915 · JJE
Abbott Laboratories
Toxicology · 76d
Cleared May 16, 1995
MPM HYDROGEL DRESSING
K950934 · MGQ
Richard Hamer Assoc., Inc.
General & Plastic Surgery · 76d
Cleared May 16, 1995
EMS I.V. START KIT
K951167 · LRS
Emergency Medical Supply, Inc.
General & Plastic Surgery · 63d
Cleared May 16, 1995
RYDER CONTACT LENS CASE MODEL 10670
K951182 · LRX
Bradstreet Clinical Research Assoc.,...
Ophthalmic · 61d
Cleared May 16, 1995
STERILE EQUIPMENT COVER
K951214 · KKX
Gulfstream Medical
General Hospital · 60d
Cleared May 16, 1995
AXSYM BENZODIAZEPINES
K951286 · JXM
Abbott Laboratories
Toxicology · 56d
Cleared May 16, 1995
AXSYM CANNABINOIDS
K951288 · JXM
Abbott Laboratories
Toxicology · 56d
Cleared May 16, 1995
KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE...
K951625 · GCJ
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 39d
Cleared May 16, 1995
NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS
K951731 · GEI
American Hydro-Surgical Instruments,...
General & Plastic Surgery · 32d
Cleared May 16, 1995
HOWMEDICE BONE PLUG
K951860 · LZN
Howmedica Corp.
Orthopedic · 25d
Cleared May 16, 1995
PFC CEMENT RESTRICTOR
K951934 · LZN
Johnson & Johnson Professionals, Inc.
Orthopedic · 21d
Cleared May 15, 1995
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY
K924306 · KNT
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 992d
Cleared May 15, 1995
TRAX(TM) CD4 TEST KIT
K925255 · GKZ
T Cell Diagnostics, Inc.
Hematology · 938d
Cleared May 15, 1995
ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBE
K926073 · FEG
Surgimark, Inc.
Gastroenterology & Urology · 895d
Cleared May 15, 1995
IMAGERT
K942346 · IYE
Impac Medical Systems, Inc.
Radiology · 364d