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
135961–135984 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1988
KONTRON INTRA-AORTIC BALLOON PUMP MODEL K2000
K874816 · DSP
Kontron Instruments, Inc.
Cardiovascular · 120d
Cleared Apr 01, 1988
COBE CML3
K880021 · DTZ
Cobe Laboratories, Inc.
Cardiovascular · 87d
Cleared Apr 01, 1988
EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
K880052 · DTJ
Baxter Healthcare Corp
Cardiovascular · 86d
Cleared Apr 01, 1988
BOVINE CALF SERUM CATALOG #A-2119
K880470 · KIS
Hyclone Laboratories, Inc.
Pathology · 58d
Cleared Apr 01, 1988
MULTISURFACE ROLLER BOTTLE (M.S.R.B.)
K880509 · KJC
Motil Plastics , Ltd.
Pathology · 51d
Cleared Apr 01, 1988
WESCOR STAIN CONCENTRATE FOR MODEL 7100 AEROSPRAY
K880544 · GJL
Wescor, Inc.
Hematology · 52d
Cleared Apr 01, 1988
DIACYTE FIXATIVE SOLUTION
K880549 · LDY
Cytocorp, Inc.
Pathology · 52d
Cleared Apr 01, 1988
ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)
K880647 · HOX
Fred Sammons, Inc.
Ophthalmic · 45d
Cleared Apr 01, 1988
EASY SHIELD ADHESIVE BANDAGE
K880675 · HOY
Eye Garter Company, Inc.
Ophthalmic · 42d
Cleared Apr 01, 1988
CALIFORNIA CONVERTIBLES (SUNGLASSES)
K880709 · HQY
Jmj World Trade Corp.
Ophthalmic · 39d
Cleared Apr 01, 1988
NON ADHERENT PAD
K880788 · FRO
Cederroth, Inc. USA
General & Plastic Surgery · 35d
Cleared Apr 01, 1988
PAREL RARE EARTH MAGNET, I.O.M., INTRAOCULAR MAG
K880855 · HPN
Richard James, Inc.
Ophthalmic · 31d
Cleared Apr 01, 1988
NUTRIENT GELATIN - PRODUCT NUMBER T2860
K880946 · JSF
Lakewood Biochemical Co., Inc.
Microbiology · 25d
Cleared Apr 01, 1988
NUTRIENT AGAR PLATE, SLANT TUBE AND BROTH TUBE
K880947 · JSG
Lakewood Biochemical Co., Inc.
Microbiology · 25d
Cleared Apr 01, 1988
PYR/ESCULIN DISK
K880950 · JTO
Remel Co.
Microbiology · 25d
Cleared Apr 01, 1988
VCTS 700S SYSTEM
K881021 · HOX
Vistech Consultants, Inc.
Ophthalmic · 22d
Cleared Apr 01, 1988
VCTS MARKETING PROGRAM SYSTEM
K881022 · HOX
Vistech Consultants, Inc.
Ophthalmic · 22d
Cleared Apr 01, 1988
VCTS 6500 SYSTEM
K881023 · HOX
Vistech Consultants, Inc.
Ophthalmic · 22d
Cleared Apr 01, 1988
DUODERM(R) CGF
K881050 · NAD
Convatec, A Division of E.R. Squibb &...
General & Plastic Surgery · 21d
Cleared Apr 01, 1988
KOI(TM) BLADE GAUGE, MODEL KOI-132
K881094 · HOE
CooperVision, Inc.
Ophthalmic · 17d
Cleared Apr 01, 1988
REGAL LATEX SURGICAL GLOVES
K881191 · KGO
Maxcare, Inc.
General Hospital · 11d
Cleared Mar 31, 1988
CO2/02 MONITOR MULTINEX
K872024 · CCI
Datascope Corp.
Anesthesiology · 310d
Cleared Mar 31, 1988
AXIAL TOME, 60, FLUORO AND TOMAX
K872825 · EHD
Axialtome Corp.
Radiology · 259d
Cleared Mar 31, 1988
HEATER WIRE BREATHING CIRCUIT
K873179 · BZE
Life Design Systems, Inc.
Anesthesiology · 232d