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
109417–109440 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 11, 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Mar 11, 1994
CEDIA DAU COCAINE ASSAY HITACHI 717 AND 704 ANALYZERS
K935904 · DIO
Microgenics Corp.
Toxicology · 91d
Cleared Mar 11, 1994
COULTER MULTI Q PREP
K935953 · GKH
Coulter Corp.
Hematology · 88d
Cleared Mar 11, 1994
COOK LAPAROSCOPIC MINI RETRACTOR SET
K936026 · HFI
Cook Urological, Inc.
Obstetrics & Gynecology · 84d
Cleared Mar 11, 1994
COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS
K936130 · LGQ
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Mar 11, 1994
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS
K936131 · LGR
Roche Diagnostic Systems, Inc.
Toxicology · 78d
Cleared Mar 11, 1994
URINARY ALBUMIN CALIBRATOR
K936201 · JIS
Dupont Medical Products
Chemistry · 72d
Cleared Mar 11, 1994
VALPROIC ACID
K936208 · LEG
Seradyn, Inc.
Chemistry · 72d
Cleared Mar 11, 1994
DMA AMYLASE (DEMAND) PROCEDURE
K940010 · CIJ
Data Medical Associates, Inc.
Chemistry · 66d
Cleared Mar 11, 1994
SHIELDTEX STERILE PATIENT EXAMINATION GLOVES
K940387 · LYY
Shieldtex Sdn Bhd
General Hospital · 49d
Cleared Mar 11, 1994
ACS O DILVENT PROTEIN DILUTION MATRIX
K940397 · JJY
Analytical Control Systems, Inc.
Chemistry · 43d
Cleared Mar 11, 1994
ORTHOPEDIC TRAY PRODUCT LINE
K940646 · LRP
Cushindu
General & Plastic Surgery · 24d
Cleared Mar 10, 1994
STRYKER PRECISION DENTAL IMPLANT SYSTEM
K921805 · DZE
Stryker Instruments
Dental · 694d
Cleared Mar 10, 1994
PELVIC C-CLAMP
K922796 · JEC
Synthes (Usa)
Orthopedic · 639d
Cleared Mar 10, 1994
ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM)
K925345 · LZO
Biomet, Inc.
Orthopedic · 504d
Cleared Mar 10, 1994
SYNTHES STERILE PINLESS EXTERNAL FIXATOR
K925460 · KTT
Synthes (Usa)
Orthopedic · 497d
Cleared Mar 10, 1994
VAS-CATH INC. OPTI-PLAST ANGIOPLASTY CATHETER
K925485 · LIT
Vas-Cath, Inc.
Cardiovascular · 496d
Cleared Mar 10, 1994
E 4000 DENTAL OPERATING CHAIR
K925567 · KLC
Dentalez Group
Dental · 492d
Cleared Mar 10, 1994
ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM
K926395 · LZO
Depuy, Inc.
Orthopedic · 444d
Cleared Mar 10, 1994
SUTTER PROXIMAL INTERPHALANGEAL JOINT
K931588 · KYJ
Sutter Corp.
Orthopedic · 344d
Cleared Mar 10, 1994
VIFI: VECTOR INTERFERENTIAL ONE
K931732 · LIH
Compliance Technology, Inc.
Neurology · 337d
Cleared Mar 10, 1994
OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM
K932519 · LZO
Osteonics Corp.
Orthopedic · 289d
Cleared Mar 10, 1994
RMHS POROUS DISTAL SLEEVE
K932574 · JDI
Smith & Nephew Richards, Inc.
Orthopedic · 287d
Cleared Mar 10, 1994
ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL
K932593 · HSB
Synthes (Usa)
Orthopedic · 286d