FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
131665–131688 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 10, 1989
VARIOUS FEMORAL HIP PROSTHESES W/SELF LOCK CERAMIC
K884952 · LZO
Protek, Inc.
Orthopedic · 162d
Cleared May 10, 1989
INTRAFORM TOTAL HIP SYSTEM
K890742 · JDI
Orthomet, Inc.
Orthopedic · 86d
Cleared May 10, 1989
ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI.
K890772 · IYO
Boston Scientific Corp
Radiology · 84d
Cleared May 10, 1989
STAT TEST KIT FOR EB-VCA IGG ANTIBODY
K891086 · LSE
Whittaker Bioproducts, Inc.
Microbiology · 70d
Cleared May 10, 1989
DIRECT BILIRUBIN FOR CONTINUOUS FLOW
K891240 · CIG
Catachem, Inc.
Chemistry · 64d
Cleared May 10, 1989
NICKLE-TITANIUM ORTHODONTIC WIRE
K891327 · FJF
American Orthodontics
Gastroenterology & Urology · 61d
Cleared May 10, 1989
CERUMEN FILTER
K891594 · ESD
Gn Danavox, Inc.
Ear, Nose, Throat · 51d
Cleared May 10, 1989
RUBBER DAM CLAMPS/FORCEPS
K892261 · EKJ
Zinnanti Surgical Instruments, Inc.
Dental · 36d
Cleared May 10, 1989
BEHIND-THE-EAR HEARING AID MODEL 46 PP PC
K892337 · ESD
Qualitone
Ear, Nose, Throat · 35d
Cleared May 09, 1989
CAVITRON/KELMAN PHACOEMULSIFIER ASPIRATOR, UNIV.
K890635 · HQC
CooperVision, Inc.
Ophthalmic · 90d
Cleared May 09, 1989
PENT CAPS
K890662 · EJJ
Jeneric/Pentron, Inc.
Dental · 89d
Cleared May 09, 1989
HI CHEM CREATININE REAGENT (PRODUCT #88809)
K890671 · CGX
Hichem Diagnostics
Chemistry · 89d
Cleared May 09, 1989
PHADIATOP PAEDIATRIC RIA AND EIA
K891135 · DHB
Pharmacia, Inc.
Immunology · 67d
Cleared May 09, 1989
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START
K891470 · CGS
Trace Scientific , Ltd.
Chemistry · 55d
Cleared May 09, 1989
CLS 962 MICROPLATE PHOTOMETER
K891869 · JJQ
Cambridge Life Sciences Plc.
Chemistry · 43d
Cleared May 09, 1989
MONI-TROL(R)
K891929 · JJY
Baxter Healthcare Corp
Immunology · 42d
Cleared May 09, 1989
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · DCK
Technicon Instruments Corp.
Immunology · 36d
Cleared May 09, 1989
AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
K892362 · DBF
Amersham Corp.
Immunology · 33d
Cleared May 09, 1989
MODIFIED ACCESS R-CLONE ANA/RF SCREENING TEST
K892421 · LJM
Lipogen, Inc.
Immunology · 29d
Cleared May 09, 1989
SPQ TM TEST SYSTEM II FOR CRP
K892526 · DCK
Atlantic Antibodies
Immunology · 28d
Cleared May 09, 1989
RECTAL SPECULA - CHELSEA-EATON, KELLY, MATHIEU
K892542 · FFN
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1989
BEST COLON CLAMP
K892550 · FFN
Zinnanti Surgical Instruments, Inc.
Gastroenterology & Urology · 28d
Cleared May 09, 1989
E653 OBLONG ABDUCTION BLOCK
K892697 · INW
Rifton Equipment For the Handicapped
Physical Medicine · 26d
Cleared May 09, 1989
E655 ADJUSTABLE ABDUCTION BLOCK W/HIP STABILIZER
K892698 · INW
Rifton Equipment For the Handicapped
Physical Medicine · 26d