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
102745–102768 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 22, 1995
PRIMA MAPLESON D CIRCUIT
K952017 · CAI
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA COAXIAL CIRCUITS
K952018 · CAI
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA ADULT GAS SAMPLING CIRCUITS
K952019 · CAI
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA PEDIATRIC ANESTHESIA CIRCUITS
K952020 · CAI
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA HYUPERINFLATION SYSTEM
K952021 · BZR
Prima, Inc.
Anesthesiology · 24d
Cleared May 22, 1995
PRIMA VOLUMN VENTILATORSS
K952022 · BZO
Prima, Inc.
Anesthesiology · 24d
Cleared May 19, 1995
HEMAGEN CHAGAS' KIT (EIA METHOD)
K930272 · MIU
Hemagen Diagnostics, Inc.
Microbiology · 850d
Cleared May 19, 1995
AT33 EMG
K930578 · HCC
Autoject Systems, Inc.
Neurology · 834d
Cleared May 19, 1995
I.V. FILTER SET
K933523 · FPB
Mediziv Medical Products 1987 , Ltd.
General Hospital · 668d
Cleared May 19, 1995
FILTRYZER(TM)
K935471 · FJI
Toray Industries (America), Inc.
Gastroenterology & Urology · 550d
Cleared May 19, 1995
PHOTOTHERAPEUTIX MODEL 2480AB
K935525 · FTC
Avex Industries , Ltd.
General & Plastic Surgery · 549d
Cleared May 19, 1995
ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY
K935807 · LJC
Bio-Rad Laboratories, Inc.
Microbiology · 533d
Cleared May 19, 1995
ACCUTEST
K940615 · KCY
Instrumed, Inc.
General & Plastic Surgery · 459d
Cleared May 19, 1995
CARDIOVIT AT-5C
K941462 · LOS
Schiller America, Inc.
Cardiovascular · 421d
Cleared May 19, 1995
BIOMERIEUX HEMOLAB COFAC II
K942049 · GJT
Biomerieux Vitek, Inc.
Hematology · 386d
Cleared May 19, 1995
HEMOLAB COFAC IX
K942050 · GJT
Biomerieux Vitek, Inc.
Hematology · 386d
Cleared May 19, 1995
SYNTHETIC ABSORBABLE SUTURE
K944937 · GAM
Johnson & Johnson International
General & Plastic Surgery · 225d
Cleared May 19, 1995
LF CT HIG PRESSURE CATHETERS
K945053 · FOZ
Mallinckrodt Group, Inc.
General Hospital · 217d
Cleared May 19, 1995
DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063
K945065 · DTN
Sorin Biomedical, Inc.
Cardiovascular · 217d
Cleared May 19, 1995
STERILE EMPTY PCA SYRINGE
K945797 · FMF
Intl. Medication Systems, Ltd.
General Hospital · 172d
Cleared May 19, 1995
SCIMED(R) VENTURE(TM) II INFUSION CATHETER
K945904 · KRA
Scimed Peripheral Interventions
Cardiovascular · 168d
Cleared May 19, 1995
QUICKVUE(R) CHLAMYDIA TEST
K946276 · LJC
Quidel Corp.
Microbiology · 147d
Cleared May 19, 1995
TIBIA-TALUS-CALCANEUS NAIL
K950394 · HSB
Smith & Nephew Richards, Inc.
Orthopedic · 107d
Cleared May 19, 1995
CUTTER, VITREOUS ANTERIOR VITRECTOMY PROBE (AVP)
K950852 · HQE
H.S. Intl. Co., Inc.
Ophthalmic · 81d