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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
137857–137880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 23, 1987
MODEL 1330 EXTENSION SET
K873042 · FPA
Pharmacia Deltec, Inc.
General Hospital · 80d
Cleared Oct 23, 1987
SODIUM/POTASSIUM REAGENT KIT
K873126 · JGS
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CHLORIDE REAGENT KIT
K873127 · JFS
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
GLUCOSE REAGENT KIT
K873128 · CGA
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CARBON DIOXIDE REAGENT KIT
K873129 · JFL
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
WASH SOLUTION KIT
K873130 · JJE
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
CREATININE REAGENT KIT
K873131 · CGX
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
BUN REAGENT KIT
K873132 · LFP
A-Kem, Inc.
Chemistry · 74d
Cleared Oct 23, 1987
LASER RESISTANT DRAPE
K873141 · KKX
Baxter Healthcare Corp
General Hospital · 74d
Cleared Oct 23, 1987
AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT
K873197 · JWH
Depuy, Inc.
Orthopedic · 71d
Cleared Oct 23, 1987
8810 PUMP-PUMP SINGLE NEEDLE DEVICE
K873279 · FIF
Cd Medical, Inc.
Gastroenterology & Urology · 67d
Cleared Oct 23, 1987
LMI CHOLANGIOGRAM TRAY
K873471 · GBZ
Lazarus Medical Innovations, Inc.
General & Plastic Surgery · 56d
Cleared Oct 23, 1987
HD-400-A/B/C HEMODIALYSIS SYSTEMS & ACCESSORIES
K873487 · FIP
Water Pure, Inc.
Gastroenterology & Urology · 53d
Cleared Oct 23, 1987
GORSK INSTRUMENT REST
K873554 · HMG
Gorsk, Inc.
Ophthalmic · 56d
Cleared Oct 23, 1987
GORSK SPONGE CONTAINMENT SYSTEM
K873555 · LWH
Gorsk, Inc.
General & Plastic Surgery · 56d
Cleared Oct 23, 1987
10CC CONTROL SYRINGE
K873588 · FMF
Medi-Plast Intl., Inc.
General Hospital · 49d
Cleared Oct 23, 1987
SMITH & NEPHEW DAYLIGHTER(TM)
K873786 · FSY
Smith & Nephew, Inc.
General & Plastic Surgery · 36d
Cleared Oct 23, 1987
TECNOL SURGEON'S CAP
K873830 · FYF
Tecnol New Jersey Wound Care, Inc.
General & Plastic Surgery · 32d
Cleared Oct 23, 1987
RETROBULBAR NEEDLE
K873848 · GDM
Healthtek, Inc.
General & Plastic Surgery · 31d
Cleared Oct 23, 1987
PHARMACIA DELTEC BAG SPIKE SET
K873876 · FPA
Pharmacia Deltec, Inc.
General Hospital · 31d
Cleared Oct 23, 1987
UNIVERSAL TOURNIQUET
K873928 · GAX
Dryden Corp.
General & Plastic Surgery · 28d
Cleared Oct 23, 1987
MICRO CULTURE MEDIA P3528, P3137, P3149, P3139
K873951 · JSJ
Lakewood Biochemical Co., Inc.
Microbiology · 25d
Cleared Oct 23, 1987
MICRO CULTURE MEDIA P3141, P3136, P3148, P3748
K873952 · KZI
Lakewood Biochemical Co., Inc.
Microbiology · 25d
Cleared Oct 23, 1987
NON-CORING HUBER TYPE NEEDLES
K873957 · FMI
Advantage Medical Systems, Inc.
General Hospital · 25d