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
126961–126984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1990
CONSTI-SSAGE VIBRATOR/MASSAGE
K900674 · ISA
Bio-Tech Co.
Physical Medicine · 17d
Cleared Mar 02, 1990
MOBILIMB H3 HAND CPM UNIT
K900794 · JFA
Toronto Medical Corp.
Physical Medicine · 10d
Cleared Mar 01, 1990
CLP CK/LD ISOENZYME/IMMUNO CONTROL
K896465 · JJT
Creative Laboratory Products, Inc.
Chemistry · 108d
Cleared Mar 01, 1990
F.A.S.T. TABLE
K896583 · IXR
Oec-Diasonics, Inc.
Radiology · 100d
Cleared Mar 01, 1990
SPECIMEN CONTAINER
K896794 · LIO
Westmark, Sterile Packing Systems,...
Microbiology · 90d
Cleared Mar 01, 1990
SPIROSCAN 4000
K896924 · BZG
Brentwood Instruments, Inc.
Anesthesiology · 79d
Cleared Mar 01, 1990
ENZYMUN TEST(R) TBK
K896991 · CEE
Boehringer Mannheim Corp.
Chemistry · 78d
Cleared Mar 01, 1990
UMI BRAIDED CATHETER CONNECTOR
K897128 · LYY
Universal Medical Instrument Corp.
General Hospital · 65d
Cleared Mar 01, 1990
ABBOTT COMMANDER PARALLEL PROCESSING CENTER
K897158 · JQW
Abbott Laboratories
Chemistry · 65d
Cleared Mar 01, 1990
COULTER URIC ACID REAGENT
K897161 · KNK
Coulter Electronics, Inc.
Chemistry · 63d
Cleared Mar 01, 1990
MODIFIED DSL-2300 ACTH RIA
K900147 · CKG
Diagnostic Systems Laboratories, Inc.
Chemistry · 49d
Cleared Mar 01, 1990
STAT FAX(TM)-2100
K900224 · JJQ
Awareness Technology, Inc.
Chemistry · 43d
Cleared Mar 01, 1990
AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
K900250 · CJE
American Research Products Co.
Chemistry · 43d
Cleared Mar 01, 1990
STERILE CARBON STEEL SURGICAL BLADE
K900266 · GES
Rahn Laboratories
General & Plastic Surgery · 42d
Cleared Mar 01, 1990
LYTENING 2Z LYTENING SYSTEM 31
K900300 · CEM
Baxter Healthcare Corp
Chemistry · 38d
Cleared Mar 01, 1990
REPEL SURGICAL GLOVE LINERS
K900310 · LYU
Depuy-Raynham
General Hospital · 38d
Cleared Mar 01, 1990
CENTERING PLUG
K900392 · LZN
Allo Pro Corp.
Orthopedic · 34d
Cleared Mar 01, 1990
SCHOLTEN FRAME
K900405 · JEB
Scholten Surgical Instruments, Inc.
General & Plastic Surgery · 31d
Cleared Mar 01, 1990
BICARBONATE REAGENTS PRODUCT #7713 & #7714
K900420 · JFL
American Research Products Co.
Chemistry · 30d
Cleared Mar 01, 1990
FIAGEN(TM) HLH.S
K900621 · CEP
Cyberfluor, Inc.
Chemistry · 21d
Cleared Mar 01, 1990
SPEC T.E.N.S. PREWIRED REPOSITIONABLE TENS ELECT.
K900656 · GXY
Labeltape Meditect, Inc.
Neurology · 20d
Cleared Feb 28, 1990
INSITUCAT VALVE STRIPPER
K885046 · DWQ
Aesculap Instruments Corp.
Cardiovascular · 450d
Cleared Feb 28, 1990
PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV
K890182 · DSY
Aesculap Instruments Corp.
Cardiovascular · 406d
Cleared Feb 28, 1990
MODEL 8500 HAND HELD PULSE OXIMETER
K893221 · DQA
Nonin Medical, Inc.
Anesthesiology · 307d