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
126049–126072 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 04, 1990
MODELS 4000/4900/6000/8000/8900, LUXAS&1700 ND:YAG
K900630 · GEX
Heraeus Lasersonics, Inc.
General & Plastic Surgery · 85d
Cleared May 04, 1990
MICROTEK MEDICAL'S BLOOD COLLECTION KIT
K900726 · JKA
Microbio-Medics, Inc.
Chemistry · 78d
Cleared May 04, 1990
B-300 COMBINATION SWITCHING DISPOSABLE HANDPIECE
K900767 · GEI
Beacon Laboratories, Inc.
General & Plastic Surgery · 77d
Cleared May 04, 1990
DACOMED NEGATIVE PRESSURE ERECTION DEVICE
K900774 · LKY
Dacomed Corp.
Gastroenterology & Urology · 73d
Cleared May 04, 1990
MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.
K900832 · JDI
Depuy, Inc.
Orthopedic · 71d
Cleared May 04, 1990
BIOSIGN HCG-ONE STEP PREGNANCY TEST
K901011 · JHI
Princeton Biomedix
Chemistry · 60d
Cleared May 04, 1990
VACUUM ERECTION DEVICE (VED)
K901223 · LKY
Mission Pharmacal Co.
Gastroenterology & Urology · 51d
Cleared May 04, 1990
CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE)
K901229 · CGX
Technicon Instruments Corp.
Chemistry · 51d
Cleared May 04, 1990
STAYEREC SYSTEM(TM)
K901318 · LKY
Osbon Medical Systems, Ltd.
Gastroenterology & Urology · 44d
Cleared May 04, 1990
MODIFIED PORGES SPEC 5* SUPRAPUBIC CATHETER
K901603 · KOB
Bivona Medical Technologies
Gastroenterology & Urology · 38d
Cleared May 03, 1990
LISS CRANIAL STIMULATOR MODEL SBL201-M
K894515 · QJQ
Medical Consultants Intl. , Ltd.
Neurology · 288d
Cleared May 03, 1990
DANTEC MENUET
K896575 · FAP
Dantec Medical, Inc.
Gastroenterology & Urology · 164d
Cleared May 03, 1990
HEARTSTART 3000
K896919 · MKJ
Laerdal Medical Corp.
Cardiovascular · 142d
Cleared May 03, 1990
MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS
K900520 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER
K900521 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS
K900522 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER
K900524 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS
K900526 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES
K900527 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES
K900528 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES
K900529 · HQY
J & B Assoc.
Ophthalmic · 90d
Cleared May 03, 1990
MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL
K900539 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 87d
Cleared May 03, 1990
CHLAMYDIAZYME DIAGNOSTIC KIT
K900543 · LJC
Abbott Laboratories
Microbiology · 87d
Cleared May 03, 1990
RICHARD-ALLAN VESSEL LOOPS
K900566 · KDC
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 85d