FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89761–89784 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 27, 1998
ALBP
K981457 · CJW
Abbott Mfg., Inc.
Chemistry · 34d
Cleared May 27, 1998
ALBG
K981468 · CIX
Abbott Laboratories
Chemistry · 34d
Cleared May 27, 1998
ACTIVE RENIN IRMA MODEL NUMBER DSL-25100
K981607 · CIB
Diagnostic Systems Laboratories, Inc.
Chemistry · 22d
Cleared May 27, 1998
SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM
K981626 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared May 26, 1998
MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD
K973360 · LDF
Medtronic Vascular
Cardiovascular · 260d
Cleared May 26, 1998
VACU*MED, GOLD EDITION CARBON DIOXIDE GAS ANALYZER
K973544 · CCK
Vacumed, Div. of Vacumetrics, Inc.
Anesthesiology · 250d
Cleared May 26, 1998
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
K973545 · CCL
Vacumed, Div. of Vacumetrics, Inc.
Anesthesiology · 250d
Cleared May 26, 1998
BRANEMARK SYSTEM DEC 600 DRILLING UNIT
K974123 · DZE
Nobel Biocare Uas, Inc.
Dental · 204d
Cleared May 26, 1998
AIRPREP SYSTEM - MODEL 9001
K974488 · KOJ
Asi Medical, Inc.
Dental · 181d
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