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
89257–89280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 26, 1998
DIMERTEST LATEX ASSAY
K974596 · DAP
Agen Biomedical , Ltd.
Hematology · 168d
Cleared May 26, 1998
HISTOFREEZER/ 17% SALICYLIC ACID-VERRUCA PLANTARIS
K980739 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 90d
Cleared May 26, 1998
CEDIA DAU EDDP ASSAY
K980746 · DJR
Boehringer Mannheim Corp.
Toxicology · 89d
Cleared May 26, 1998
DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER,...
K981043 · KPO
Solution Technologies
Gastroenterology & Urology · 67d
Cleared May 26, 1998
INTRAVASCULAR RETRIEVAL DEVICE
K981061 · GCC
Med Institute, Inc.
General & Plastic Surgery · 64d
Cleared May 26, 1998
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
K981099 · JHX
Dade Behring, Inc.
Chemistry · 61d
Cleared May 26, 1998
IL TEST PLASMINOGEN
K981200 · GGP
Instrumentation Laboratory CO
Hematology · 54d
Cleared May 26, 1998
TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS)
K981206 · GKP
Cardiovascular Diagnostics, Inc.
Hematology · 55d
Cleared May 26, 1998
QUIKPAC II ONE STEP PHENCYCLIDINE (PCP) TEST
K981292 · LCM
Syntron Bioresearch, Inc.
Toxicology · 47d
Cleared May 22, 1998
DEPUY ACE RING SKULL PINS-MRI, DEPUY ACE SPRING LOADED TONG PIN-MRI, DEPUY...
K974245 · LXT
Depuy Ace Medical Co.
Orthopedic · 191d
Cleared May 22, 1998
DOWNSCAN LT
K974882 · LMD
Merlin Engineering Works, Inc.
Radiology · 143d
Cleared May 22, 1998
SONOS 5500 ULTRASOUND IMAGING SYSTEM
K980687 · IYO
Hewlett-Packard Co.
Radiology · 88d
Cleared May 22, 1998
CABLE SCREW WITH INTEGRAL CRIMP
K980690 · JDQ
Pioneer Surgical Technology
Orthopedic · 88d
Cleared May 22, 1998
SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM
K980710 · GEX
Schwartz Electro-Optics, Inc.
General & Plastic Surgery · 87d
Cleared May 22, 1998
FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM
K980713 · JWH
Howmedica Corp.
Orthopedic · 87d
Cleared May 22, 1998
UROMED SLING KIT
K980717 · KNA
Uromed Corp.
Obstetrics & Gynecology · 87d
Cleared May 22, 1998
ACCU-CHEK COMFORT CURVE TEST STRIPS
K980731 · LFR
Boehringer Mannheim Corp.
Chemistry · 86d
Cleared May 22, 1998
IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS
K980781 · JWH
Implex Corp.
Orthopedic · 81d
Cleared May 22, 1998
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
K980788 · JDW
Alphatec Mfg., Inc.
Orthopedic · 81d
Cleared May 22, 1998
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
K980858 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 78d
Cleared May 22, 1998
CLEAR (TM) SPECIAL NIT COMB
K981037 · LJL
Care Technologies, Inc.
General Hospital · 64d
Cleared May 22, 1998
APR -T REVISION HIP STEM
K981211 · LPH
Sulzer Orthopedics, Inc.
Orthopedic · 50d
Cleared May 22, 1998
STC OPIATES MICRO-PLATE EIA (ORASURE APPLICATION)
K981341 · DJG
OraSure Technologies, Inc.
Toxicology · 39d
Cleared May 21, 1998
BISSINGER DETACHABLE BIPOLAR COAGULATION-FORCEPS
K970968 · HET
Guenter Bissinger Medizintechnik GmbH
Obstetrics & Gynecology · 430d